BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 21571731 · Received March 11, 2025

    Report

    Report Number
    1823260-2025-00684
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Date of Event
    February 10, 2025
    Report Date
    March 11, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE 1 WAS INITIALLY TESTED USING THE CRP4 REAGENT LOT NUMBER 813726 AND REPEATED USING THE CRP4 REAGENT LOT NUMBER 831339. SAMPLE 2 AND SAMPLE 3 WERE INITIALLY TESTED AND REPEATED USING THE CRP4 REAGENT LOT NUMBER 831339. THE EXPIRATION DATES FOR BOTH CRP REAGENT LOT NUMBERS WERE NOT PROVIDED. A GENERAL REAGENT ISSUE CAN BE EXCLUDED AS NO FURTHER ISSUES WERE REPORTED AND A CORRECT RERUN WAS PERFORMED WITH THE SAME REAGENT. THE FIELD SERVICE ENGINEER (FSE) PERFORMED THE FOLLOWING ACTIONS: DECONTAMINATED THE SAMPLE PROBES AND CHECKED THEIR ADJUSTMENT. REPLACED REAGENT PROBES AND SYRINGE SEALS AS A PROACTIVE MEASURE. CHECKED THE WATER PRESSURE AND GEAR PUMP PRESSURE. PERFORMED INSTRUMENT DECONTAMINATION AS A PROACTIVE MEASURE. ADJUSTED THE RINSING LEVELS. REPLACED THE HALOGEN LAMP AND REACTION CELLS. PERFORMED LOG ANALOGUE DIGITAL CONVERTER ADJUSTMENT AS A PROACTIVE MEASURE. REPLACED THE DEGASSER AND THE MIXER. CLEANED THE HIGH-CONCENTRATED LIQUID VALVE. ADJUSTED THE MIXER. THE FSE ALSO PERFORMED SAMPLE TESTING, CALIBRATION, AND QC AND THE RESULTS WERE ACCEPTABLE. THE ROOT CAUSE WAS RELATED TO SERVICE AND OPERATOR MAINTENANCE OR COMPONENT ISSUES.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 3 PATIENTS' SAMPLES TESTED WITH CRP4 ASSAY ON A COBAS 8000 C702 MODULE. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 0.18 MG/L. REPEAT RESULT: 23.89 MG/L. THE REPEAT RESULT WAS DEEMED TO BE CORRECT. SAMPLE 2 AND SAMPLE 3 WERE TESTED ON (B)(6) 2025: SAMPLE 2 (PATIENT 2): INITIAL RESULT: 0.42 MG/L. REPEAT RESULT: 0.2 MG/L. SAMPLE 3 (PATIENT 3): INITIAL RESULT: 0.32 MG/L. REPEAT RESULT: 0.2 MG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339882 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown