BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 24376914 · Received February 18, 2026

    Report

    Report Number
    1823260-2026-00563
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    January 27, 2026
    Report Date
    February 18, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 882078. THE EXPIRATION DATE WAS NOT PROVIDED. THE CALIBRATION AND QC WERE ACCEPTABLE. THE FIELD SERVICE REPRESENTATIVE REPLACED THE GEAR PUMP HEAD. HE FOUND THAT THE CLIP ON THE RINSE MECHANISM WAS PARTIALLY DETACHED. HE REPLACED THE CLIP BUT FOUND A CRACK IN THE CLIP MOUNTING POINT. HE REPLACED THE ARM ON THE RINSE MECHANISM AND ENSURED THAT THE CLIP REMAINED SEATED. HE PERFORMED CHECKS AND TESTS WITH ACCEPTABLE RESULTS. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM GEN.2 RESULTS FOR "SEVERAL" PATIENT SAMPLES ON A COBAS 8000 C702 MODULE. ONLY ONE EXAMPLE WAS PROVIDED. THE INITIAL RESULT WAS 6.4 MG/DL, AND THE REPEATED RESULT WAS 9.2 MG/DL. THE REPEATED RESULT WAS OBTAINED ON ANOTHER MODULE AND WAS BELIEVED TO BE CORRECT. THE SAMPLES WERE REPEATED BECAUSE THE STAFF NOTICED A HIGH FREQUENCY OF CRITICAL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491601 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown