BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 20466600 · Received October 16, 2024

    Report

    Report Number
    1823260-2024-02995
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    October 7, 2024
    Report Date
    October 16, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHOSPHATE REAGENT LOT AND EXPIRY DATE WERE REQUESTED BUT WERE NOT PROVIDED. REAGENT ISSUES WERE EXCLUDED AS THE CORRECT REPEAT MEASUREMENTS WERE PERFORMED WITH THE SAME REAGENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE GEAR PUMP HEAD (GPH). THE INVESTIGATION DETERMINED THESE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF DISCREPANT HIGH PHOSPHATE RESULTS FOR TWO PATIENT SAMPLES ON A COBAS 8000 C702 MODULE. FOR PATIENT SAMPLE 1, THE INITIAL PHOSPHATE RESULT WAS 1.98 MMOL/L AND THE REPEAT RESULT WAS 0.98 MMOL/L. FOR PATIENT SAMPLE 2, THE INITIAL PHOSPHATE RESULT WAS 2.96 MMOL/L AND THE REPEAT RESULT WAS 1.19 MMOL/L. FOR BOTH SAMPLES, THE REPEAT RESULT WAS DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034624 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown