BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1063546 · Received June 20, 2008

    Report

    Report Number
    1823260-2008-04874
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT WITH DISCREPANT RESULTS REPORTED. NO ADVERSE EVENTS REPORTED IN ASSOCIATION WITH THE INCORRECT RESULTS. INITIAL GLUCOSE 94.8 MG/DL, REPEATED 3 TIMES ON SAME ANALYZER GIVING RESULTS OF 242.5, 96.8 AND 95.5 MG/DL. SAME SAMPLE REPEATED TWICE ON DIFFERENT ANALYZER, SAME METHODOLOGY GIVING RESULTS OF 98.4 AND 96.8 MG/DL. THE ERRONEOUS RESULT (242.5 MG/DL) WAS REPORTED. INITIAL CO2 RESULT 24.8 MMOL/L, REPEATED TWICE GIVING RESULTS OF 31.8 AND 25.1 MMOL/L. THE FIELD SERVICE REPRESENTATIVE FOUND THE CAUSE OF THE DISCREPANCY TO THE BAD REAGENT PACKS WHICH WERE REPLACED. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I800

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR