Automated analyzer and analytical method

Abstract

This invention provides an automated analyzer and analytical method capable of detecting abnormalities in mechanisms, reagents, and consumables that are directly or indirectly involved in the analysis. [Solution] The system includes a mechanism used for analyzing a sample, which includes an analysis unit for analyzing the sample; a storage unit 22 that stores mechanism history information, which includes at least one of the mechanism's operation history information, cleaning history information, and component configuration history information; a determination unit 23 that makes an abnormality determination based on the mechanism history information; and an output unit that outputs abnormality information to the analysis results measured using the mechanism and the measurement unit 9 when the determination unit 23 detects an abnormality related to the mechanism.

Description

Technical Field

[0001] The present invention relates to an automatic analyzer and an analysis method.

Background Art

[0002] An automatic analyzer is a device that measures a mixed solution obtained by reacting a sample and a reagent and measures the components contained in the sample. In the field of this automatic analyzer, a technique for issuing a warning indicating an abnormality of a reagent or a cleaning solution for each individual measurement result has been disclosed (see Patent Document 1).

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] According to Patent Document 1, although abnormal information related to reagents and consumables that directly contribute to analysis (for example, shortage of reagents used for the purpose of reacting with a sample, etc.) can be captured, abnormal information related to mechanisms, reagents, and consumables that indirectly contribute to analysis (for example, abnormality during mechanism cleaning before analysis) cannot be captured.

[0005] Therefore, an object of the present invention is to provide an automatic analyzer and an analysis method capable of capturing abnormalities in mechanisms, reagents, and consumables that are not only directly but also indirectly related to analysis.

Means for Solving the Problems

[0006] The present invention includes multiple means for solving the above problems, but one example is a mechanism used for analyzing a sample, which includes an analysis unit for analyzing the sample; a storage unit for storing mechanism history information, which includes at least one of the following: operation history information, cleaning history information, and component configuration history information of the mechanism; a determination unit for determining abnormalities based on the mechanism history information; and an output unit that outputs abnormality information to the analysis results measured using the mechanism and the analysis unit when the determination unit detects an abnormality related to the mechanism. [Effects of the Invention]

[0007] According to the present invention, it is possible to detect abnormalities in mechanisms, reagents, and consumables that are directly or indirectly involved in the analysis. Other issues, configurations, and effects will be clarified by the following description of embodiments. [Brief explanation of the drawing]

[0008] [Figure 1] A diagram illustrating the configuration of the automated analyzer in the embodiment. [Figure 2] A schematic diagram of the system detergent flow path in the automated analyzer of the embodiment. [Figure 3] A diagram showing the configuration of the analysis results obtained from the automated analyzer of the embodiment. [Figure 4] A diagram showing the link between the mechanism ID in the automated analyzer of the embodiment and the latest mechanism information held by each mechanism. [Figure 5] A diagram showing the schema of mechanism history information in the automated analyzer of the embodiment. [Figure 6] A diagram showing the configuration of the latest information on the mechanism in the automated analyzer of the embodiment. [Figure 7] A diagram showing the link between the latest operational information and operational abnormality judgment criteria information for the automated analyzer of the embodiment. [Figure 8] A diagram showing the linking of cleaning information and detergent information from the latest mechanism information in the automated analyzer of the embodiment. [Figure 9] A diagram showing the link between component configuration information and component information for the latest mechanism information in the automated analyzer of the embodiment. [Figure 10]A sequence diagram showing the output flow of analysis results in the automated analyzer of the embodiment. [Figure 11] A flowchart illustrating the process from receiving a dispensing instruction to outputting analysis results in the automated analyzer of the embodiment. [Modes for carrying out the invention]

[0009] Embodiments of the automated analyzer and analytical method of the present invention will be described below with reference to Figures 1 to 11. In the drawings used herein, the same or corresponding components are denoted by the same or similar reference numerals, and repeated descriptions of these components may be omitted.

[0010] First, the overall configuration and operation of the automated analyzer will be explained using Figures 1 and 2. Figure 1 is a configuration diagram of the automated analyzer 100, which is an embodiment of the present invention. Figure 2 is a schematic diagram of the system detergent flow path in the automated analyzer 100 of this embodiment.

[0011] The automated analyzer 100 shown in Figure 1 mainly comprises a sample dispensing mechanism 1, a sample disk 2, a reaction disk 4, a reagent dispensing mechanism 6, a reagent disk 7, a measurement unit 9, a washing mechanism 10, a control device 20, and an operating device 30.

[0012] The sample disk 2 holds multiple sample containers 3 containing the samples to be analyzed. The sample disk 2 is rotatable and has a disc shape. The rotational motion of the sample disk 2 transports the sample containers 3 to be dispensed to the dispensing position of the sample dispensing mechanism 1. Alternatively, instead of or in addition to the sample disk 2, a sample holder that holds one sample container 3 or a sample rack that holds multiple sample containers 3 may be transported from a predetermined position to the dispensing position by a sample transport device.

[0013] The reaction disk 4 holds a plurality of reaction vessels 5 for performing reactions and measurements. Note that the reaction disk 4 is rotatable and has a disk shape. The reaction vessel 5 held by the reaction disk 4 is a container for containing a mixed solution obtained by mixing a sample and a reagent and causing a reaction, and has a heat retention function for keeping the temperature constant.

[0014] The sample dispensing mechanism 1 sucks the sample from the sample container 3 conveyed to the dispensing position by the sample disk 2. Then, the sample dispensing mechanism 1 dispenses the sucked sample into the reaction vessel 5 held by the reaction disk 4.

[0015] The reagent disk 7 stores a plurality of reagent containers 8 while keeping them refrigerated. Each reagent container 8 is filled with a first reagent, a second reagent, a third reagent, a reagent necessary for pre-treatment of analysis, a detergent, etc. for mixing and reacting with the sample. The reagent disk 7 is rotatable and has a disk shape.

[0016] The reagent dispensing mechanism 6 is a mechanism for dispensing the reagent or detergent filled in the reagent container 8 into the reaction vessel 5 held by the reaction disk 4. The reagent dispensing mechanism 6 dispenses the reagent or detergent at a predetermined timing in the process including analysis or its pre-treatment and cleaning.

[0017] The measurement unit 9 measures the concentration, etc. of the substance to be measured from the mixed solution of the sample and the reagent during or after the reaction in the reaction vessel 5. The measurement methods include a method of measuring transmitted light or a method of measuring the amount of light emission, etc., and vary depending on the substance to be measured.

[0018] The operation log of the mechanism used for analysis is saved in the storage unit 22 (Fig. 4) in the control device 20 of the automatic analyzer 100 simultaneously with the implementation of the operation.

[0019] The cleaning mechanism 10 is composed of a discharge nozzle for discharging cleaning water and a detergent, a suction nozzle for sucking a reaction solution, etc. The cleaning mechanism 10 cleans the reaction vessel 5 with cleaning water and a detergent.

[0020] Furthermore, in order to protect the operation of the various drive mechanisms described above, the device is equipped with a top cover 11, a reagent disc lid 13 to protect the reagent input section of the reagent disc 7, and a sample disc lid 12 to protect the sample input section of the sample disc 2, as shown in Figure 1.

[0021] The top cover 11 is provided with a top cover lock mechanism (not shown) to prevent opening and closing at times other than necessary, the reagent disk lid 13 is provided with a reagent disk lid lock mechanism 15 to prevent opening and closing at times other than necessary, and the sample disk lid 12 is provided with a sample disk lid lock mechanism 14 to prevent opening and closing at times other than necessary. The top cover lock mechanism, reagent disk lid lock mechanism 15, and sample disk lid lock mechanism 14 are connected to the control device 20, which controls their locking and unlocking.

[0022] The control device 20 is connected to the equipment within the automated analyzer 100 described above and controls the operation of each piece of equipment and mechanism within the automated analyzer 100. As will be described in detail later, the control device 20 is composed of a computer equipped with a CPU, memory, storage medium, etc., and performs calculation processing to determine the concentration of a predetermined component in the sample from the detection results of the measurement unit 9.

[0023] The control device 20 controls the operation of each device based on various programs stored in the memory device. In addition to the various programs used for measuring the sample, the memory device stores various parameters input via the input device, information on the sample to be measured (such as sample type information), and measurement results.

[0024] The control processes for the operations performed by the control device 20 may be combined into a single program, divided into multiple programs, or a combination of these. Furthermore, some or all of the programs may be implemented using dedicated hardware or may be modularized.

[0025] The operating device 30 consists of a display unit 30a such as a display and input devices such as a keyboard and mouse.

[0026] The display unit 30a is a display device such as a liquid crystal display that displays various information from the automated analyzer 100 to the operator, including input screens for various parameters and settings, analysis data for the initial or re-examination, measurement results, reagent information, etc. It can also be a touch panel that doubles as an input unit.

[0027] Furthermore, the operating device 30 and the control device 20, which has a storage unit, CPU, memory, etc., may be composed of a computer, and may be composed of one computer or multiple computers, and are not particularly limited.

[0028] Next, we will explain the detergent flow path provided in the automatic analyzer 100 using Figure 2.

[0029] In this embodiment, the detergent is the liquid discharged by the cleaning mechanism 10 into the reaction vessel 5. The detergent discharged by the cleaning mechanism 10 is filled into an external detergent bottle 16. The external detergent bottle 16 is connected to a detergent channel 17, which is connected to the discharge nozzle of the cleaning mechanism 10. A waste liquid channel 18 is connected to the suction nozzle of the cleaning mechanism 10.

[0030] The cleaning mechanism 10 discharges detergent, which is filled in an external detergent bottle 16, into the reaction vessel 5 via the detergent flow path 17. The cleaning mechanism 10 also sucks up the detergent discharged into the reaction vessel 5 and treats it as waste liquid via the waste liquid flow path 18. The detergent flow path 17 can be closed and opened via the cleaning mechanism 10.

[0031] When replacing the external detergent bottle 16, the user can replace the detergent by blocking the flow path, and after the replacement is complete, the detergent can be used by opening the flow path.

[0032] The various mechanisms described above are used for the analysis of the sample, and the measurement unit 9 is the analysis unit that performs the analysis of the sample. It should be noted that the mechanisms in this invention are not limited to those described above, and can also include various existing configurations within current automated analyzers, as well as new mechanisms to be developed in the future.

[0033] Next, we will explain the warnings output by the automated analyzer 100.

[0034] The automated analyzer 100 is configured to output a warning to the user when any abnormality occurs. There are two types of warnings output: system alarms and data alarms.

[0035] A system alarm is a warning issued when an abnormality occurs affecting the entire system, such as an abnormal temperature, insufficient dispensing, or abnormal shutdown. A key feature of system alarms is that they provide users with real-time information about the abnormal condition by issuing a warning at the moment the abnormality occurs.

[0036] On the other hand, data alarms are alarms that indicate anomalies detected in individual analyses. A key feature of data alarms is that by assigning anomaly information to individual analysis results, it becomes possible to identify and track analysis results affected by anomalies from among a large number of analysis results, including those unaffected by the anomaly.

[0037] Next, an overview of the mechanism that enables the detection of abnormalities in mechanisms, reagents, and consumables directly and indirectly involved in analysis according to the present invention will be explained using Figures 3 to 11. Figure 3 shows the sequence for assigning a data alarm, using the expiration date of detergent as an example.

[0038] Figure 3 shows a sequence of events, specifically focusing on the reagent dispensing mechanism 6 and the reaction disk 4 (including the operation of the measurement unit 9) from the mechanisms involved in the analysis. The example in Figure 3 shows a case where detergent A, used to clean the reagent dispensing mechanism 6, has expired.

[0039] As shown in Figure 3, assume that the reagent dispensing mechanism 6 is washed with detergent A before a certain analysis "Test 01" starts reacting, then the expiration date of detergent A expires after the reagent for Test 01 is dispensed, the reagent dispensing mechanism 6 is washed with detergent A again, another analysis "Test 02" starts reacting, and then the reagent dispensing mechanism 6 dispenses the reagent for Test 02.

[0040] In this situation, Test 01 dispenses reagents from the reagent dispensing mechanism 6, which has been cleaned with detergent A before its expiration date. Therefore, although detergent A has expired by the time the measurement data is output, it has not expired at the time of cleaning, and the mechanism was not cleaned with expired detergent. For this reason, it can be concluded that the mechanism does not affect the analysis results.

[0041] On the other hand, in Test 02, the reagent is dispensed through reagent dispensing mechanism 6, which has been cleaned with detergent A after its expiration date. Therefore, although detergent A has not expired by the time the measurement data is output due to replacement, it has expired at the time of cleaning. Thus, it can be concluded that the mechanism being cleaned with expired detergent has an impact on the analysis results.

[0042] Herein, when assessing the impact on the above analysis results, there is a problem in that the information directly related to each analysis, namely the abnormal information of the mechanisms, reagents, and consumables used within each section of "Test 01 Analysis Operation" and "Test 02 Analysis Operation" shown in the "Analysis Operation" line in Figure 3, is insufficient to capture abnormal conditions during the cleaning process before analysis.

[0043] Furthermore, if the expiration of detergent is notified to the user solely by a system alarm, the user will be aware of the fact that detergent A has expired, but if they try to determine which analysis results were actually affected by the expiration of detergent A, as shown by the "System Alarm" line at the bottom of Figure 3, simply tracking the analysis results after the system alarm occurs does not reveal which analysis results were affected, and it is extremely difficult to determine that the expiration of detergent did not affect Test 01.

[0044] Therefore, in order to determine the impact on the above analysis results, information indirectly related to each analysis, namely abnormalities in the mechanisms, reagents, and consumables used outside of the above-mentioned intervals, is captured, and the analysis results affected by these abnormalities are indicated to the user via a data alarm. The means for capturing these abnormalities will be described in detail below.

[0045] First, the control device 20 will be explained using Figure 4.

[0046] As shown in Figure 4, the control device 20 includes a control unit 21, a storage unit 22, and a determination unit 23.

[0047] The control unit 21 controls each mechanism of the automatic analyzer 100, acquires mechanism information, stores data in the memory unit 22, requests a judgment from the judgment unit 23, and communicates information with the operating device 30.

[0048] In this embodiment, the storage unit 22 stores mechanism history information (see Figure 5, details described later) for each mechanism, which includes at least one of mechanism operation history information, cleaning history information, and component configuration history information, and mechanism analysis information (Figure 6, details described later) for each analysis. Preferably, the storage unit 22 and the control unit 21 described above perform a storage step in which mechanism history information, which includes at least one of mechanism operation history information, cleaning history information, and component configuration history information, is stored.

[0049] When the control unit 21 outputs the analysis results to the operating device 30, the determination unit 23 performs an abnormality determination based on the mechanism history information and mechanism analysis information stored in the storage unit 22, and adds a data alarm to the analysis results. Preferably, the determination unit 23 performs an abnormality determination step based on the mechanism history information stored in the storage step.

[0050] Next, we will explain the mechanism history information using Figure 5.

[0051] In the automated analyzer 100, the control unit 21 stores the mechanism history information of each mechanism in the storage unit 22 in a data structure as shown in Figure 5.

[0052] The mechanism history information consists of basic information, operation history, cleaning history, and component configuration history. Basic information includes the mechanism ID and mechanism name. Operation history stores multiple operation records, cleaning history stores multiple cleaning records, and component configuration history stores multiple component configuration records. Operation information includes the operation time and operation logs obtained during the operation process. Cleaning information includes the detergent ID used for cleaning and the cleaning time. Component configuration information includes the IDs of the components installed in the mechanism.

[0053] Next, we will explain the mechanism analysis information using Figure 6.

[0054] As shown in Figure 6, the mechanism analysis information consists of an analysis ID and the latest mechanism information. The analysis ID is an ID assigned to each analysis item performed by the automated analyzer 100. The latest mechanism information is information extracted from the operation history information, cleaning history information, or component configuration history information in the mechanism history information, at the time the mechanism performed the analysis operation.

[0055] Next, we will explain the data structure of the analysis results using Figure 7.

[0056] The analysis results are generated by a series of analytical operations. As shown in Figure 7, the analysis results consist of basic information, mechanism information, reagent information, results, and any attached data alarms. The basic information includes the analysis ID and analysis name. The mechanism information contains the mechanism ID of the mechanism required for the analysis, and as shown in Figure 5, the latest mechanism information can be obtained through this mechanism ID. The reagent information contains the reagent ID. The results section has different output content depending on the measurement item and can take the form of concentration, absorbance, pass / fail judgment, etc.

[0057] Next, we will explain the registration process for mechanism history information and mechanism analysis information using Figure 8. Figure 8 is an example of a sequence showing the data flow, with the reagent dispensing mechanism 6 and reaction disk 4 (including the operation of the measurement unit 9) extracted from the mechanisms involved in the analysis.

[0058] As shown in Figure 8, when the reagent dispensing mechanism 6 is cleaned, the control unit 21 reflects the cleaning information of this cleaning in the cleaning history information in the mechanism history information corresponding to the reagent dispensing mechanism 6 stored in the memory unit 22. When the user replaces a part of the reagent dispensing mechanism 6, the control unit 21 reflects the component configuration information of the replaced part in the component configuration history information in the same mechanism history information. When the reagent dispensing mechanism 6 is operating, the control unit 21 reflects the operation information in the operation history information in the same mechanism history information.

[0059] Similarly, in the reaction disk 4, the control unit 21 reflects the corresponding information in the mechanism history information in the storage unit 22 corresponding to the reaction disk 4 in response to various events (cleaning, parts replacement, mechanism operation).

[0060] When performing sample analysis, the control unit 21 obtains the latest mechanism information from the mechanism history information at the timing of each analysis operation of each mechanism, links it with the analysis ID, and stores it in the mechanism analysis information in the storage unit 22. When the reaction is completed and the analysis results are output, the storage unit 22 will have all the mechanism analysis information corresponding to that analysis.

[0061] Next, we will explain the detergent data alarm detection when outputting analysis results.

[0062] When outputting analysis results, the determination unit 23 receives a determination request from the control unit 21, collects information necessary for abnormality determination from the mechanism analysis information in the storage unit 22, and determines whether or not a data alarm needs to be issued.

[0063] Figure 9 shows the determination process of the determination unit 23, using the expiration date of the detergent as an example.

[0064] The determination unit 23 receives a determination request from the control unit 21 and uses the analysis ID and mechanism ID in the analysis results as keys to identify the latest mechanism information for the corresponding analysis from the mechanism analysis information in the storage unit 22. Subsequently, the determination unit 23 identifies the detergent ID of the detergent used for cleaning from the latest cleaning information in the latest mechanism information.

[0065] Subsequently, the determination unit 23 compares the cleaning time of the latest detergent information with the expiration date of the detergent information. If the cleaning time is after the expiration date, it determines that the mechanism was cleaned with expired detergent and notifies the control unit 21 that a data alarm for expired detergent is required.

[0066] The control unit 21 receives the determination result from the determination unit 23 and adds a data alarm to the analysis result.

[0067] Next, we will explain the output screen of the analysis results using Figure 10. Figure 10 shows an example of the display in the situation shown in Figure 3.

[0068] As shown in Figure 10, the analysis results are displayed on the analysis result display screen 31 on the display unit 30a of the operating device 30. The determination unit 23 detects any abnormalities related to the mechanism, and a data alarm is added to the analysis results. If any abnormality is found, the determination unit 23 displays the analysis result display screen 31 on the display unit 30a of the operating device 30 as abnormality information for the analysis results measured using the mechanism and the measurement unit 9. For example, the determination unit 23 displays the data alarm corresponding to the data alarm column on the analysis result display screen 31. Preferably, the process of displaying this analysis result display screen 31 corresponds to an output step in which abnormalities related to the mechanism are output for the analysis results measured using the mechanism and the measurement unit 9 when an abnormality related to the mechanism is detected in the determination step.

[0069] As shown in Figure 10, it is desirable to output abnormal information along with the analysis results on the analysis results display screen 31, but it is also acceptable to display the abnormal information independently of the analysis results measured using the mechanism and measurement unit 9.

[0070] The above processing flow will be explained with reference to the flowchart shown in Figure 11.

[0071] First, as shown in Figure 11, when the control unit 21 confirms the input of an analysis request (S10), it operates each mechanism in the automatic analyzer 100 to perform the analysis process, and stores the state of operation at that time in the storage unit 22 as mechanism history information and mechanism analysis information (S11).

[0072] Subsequently, the control unit 21 calculates the analysis result (S12), and the determination unit 23 determines whether or not there was a problem (no abnormality) in the analysis result itself (S13). If it is determined that there is no problem with the analysis result, the process proceeds to step S14, where the determination unit 23 determines whether or not there was a problem (no abnormality) in the state memory of the analysis process in the analysis for which it was determined that there was no problem with the analysis result (S14).

[0073] If it is determined in step S14 that there is no problem with storing the state of the analysis process, the process proceeds to step S16, where the control unit 21 stores the analysis results in the storage unit 22 and displays the analysis results on the analysis result display screen 31 (S16), and then completes one analysis process (S17).

[0074] If a problem is determined in step S13 or step S14, the process proceeds to step S15, and a data alarm is displayed on the analysis result display screen 31 of the display unit 30a (S15).

[0075] The above describes a configuration in which the determination unit 23 performs abnormality determination regarding the degree of cleaning of the mechanism based on cleaning history information, with regard to the expiration date and the stabilization period after opening of the detergent. However, the configuration for performing abnormality determination is not limited to this.

[0076] The following describes a method for determining abnormalities in the operation of a mechanism based on operation history information, focusing on motor operation or pressure fluctuations when the mechanism is equipped with a motor, and a method for determining abnormalities in the reliability of a mechanism based on component configuration history information, focusing on whether a component is genuine or from a recalled lot.

[0077] When performing abnormality detection related to the operation of a mechanism, based on motor operation or pressure fluctuations, the latest operation information is used instead of the latest cleaning information shown in Figure 9.

[0078] In this case, the determination unit 23 receives a determination request from the control unit 21, refers to the latest operation information, and determines from the operation log whether there is an abnormality in motor operation or pressure fluctuation, such as when aspirating a sample or reagent. If an abnormality is found, it returns a determination result to the control unit 21 indicating that a data alarm corresponding to the operation abnormality needs to be added.

[0079] Furthermore, when performing an abnormality determination regarding the reliability of the mechanism based on whether the parts are genuine or belong to a recalled lot, the latest parts configuration information is used instead of the latest cleaning information shown in Figure 9.

[0080] The determination unit 23 receives a determination request from the control unit 21, refers to the latest component configuration information, searches for internally managed component information using the component ID of the component group constituting the mechanism as a key, and checks whether it is a genuine product and whether it is from a lot subject to recall. If an abnormality is found, it returns a determination result to the control unit 21 indicating that a data alarm corresponding to the component configuration abnormality needs to be triggered.

[0081] Next, the effects of this embodiment will be described.

[0082] The automated analyzer 100 of this embodiment described above includes a mechanism used for analyzing a sample, which includes an analysis unit for analyzing the sample; a storage unit 22 (storage step) for storing mechanism history information, which includes at least one of the mechanism's operation history information, cleaning history information, and component configuration history information; a determination unit 23 (determination step) for determining abnormalities based on the mechanism history information; and an output unit (output step) for outputting abnormality information to the analysis results measured using the mechanism and the measurement unit 9 when the determination unit 23 detects an abnormality related to the mechanism.

[0083] With the above configuration, the automated analyzer 100 of this embodiment can capture information indirectly related to each analysis, that is, abnormalities in mechanisms, reagents, and consumables used outside of the above-mentioned intervals, and can show the user the analysis results affected by the abnormalities through a data alarm. Thus, it is possible to provide an automated analyzer that can capture abnormalities in mechanisms, reagents, and consumables that are involved not only directly but also indirectly in the analysis.

[0084] Furthermore, the analysis results display screen 31 outputs anomaly information along with the analysis results, making it easier for users to understand which analysis results indicate anomalies in the analysis process.

[0085] <Other> It should be noted that the present invention is not limited to the embodiments described above, and various modifications and applications are possible. The embodiments described above are explained in detail for the purpose of clearly illustrating the present invention, and are not necessarily limited to those having all the configurations described. [Explanation of Symbols]

[0086] 1…Specimen dispensing mechanism (mechanism) 2…Specimen disk (mechanism) 3…Specimen container 4…Reaction disk (mechanism) 5…Reaction vessel (mechanism) 6… Reagent dispensing mechanism (mechanism) 7…Reagent disk (mechanism) 8…Reagent containers 9...Measurement section (analysis section, mechanism) 10…Cleaning mechanism (mechanism) 11…Top cover (mechanism) 12…Specimen disk lid 13… Reagent disk lid 14. Specimen disk lid locking mechanism (mechanism) 15…Reagent disk lid locking mechanism (mechanism) 16…Detergent bottles for outdoor use 17…Detergent flow path (mechanism) 18…Waste liquid flow path (mechanism) 20...Control device 21... Control Unit 22...Storage section 23…Judgment section 30...Operating device 30a...Display section 31…Analysis result display screen (output section) 100…Automatic analyzer

Claims

1. A mechanism used for analyzing the sample, including an analysis unit for analyzing the sample, A storage unit that stores mechanism history information, which includes at least one of the following: operation history information of the mechanism, cleaning history information, and component configuration history information. A determination unit that performs abnormality determination based on the aforementioned mechanism history information, The system includes an output unit that outputs abnormality information to the mechanism and the analysis results measured using the analysis unit when the determination unit detects an abnormality related to the mechanism. Automatic analyzer.

2. In the automated analyzer described in claim 1, The output unit outputs the abnormal information along with the analysis results. Automatic analyzer.

3. In the automated analyzer described in claim 1, When the aforementioned mechanism includes a motor, The determination unit performs an abnormality determination regarding the operation of the mechanism based on the operation history information, targeting motor operation or pressure fluctuations. Automatic analyzer.

4. In the automated analyzer described in claim 1, The determination unit performs an abnormality determination regarding the degree of cleaning of the mechanism based on the cleaning history information, with respect to the expiration date and the stabilization period after opening of the detergent. Automatic analyzer.

5. In the automated analyzer described in claim 1, The determination unit determines whether a part is genuine or from a lot subject to recall, and performs an abnormality determination regarding the reliability of the mechanism based on the part configuration history information. Automatic analyzer.

6. An analytical method in an automated analyzer comprising a mechanism used for analyzing a sample, including an analysis unit for analyzing the sample, A storage step that stores mechanism history information, which includes at least one of the following: operation history information of the mechanism, cleaning history information, and component configuration history information. A determination step in which an abnormality is determined based on the mechanism history information stored in the above storage step, The determination step includes an output step that outputs abnormal information for the analysis results measured using the mechanism and the analysis unit when an abnormality is detected in the determination step. Analysis method.

Images