BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1777447 · Received September 25, 2007

    Report

    Report Number
    1823260-2007-08371
    Event Type
    Malfunction
    Date Received
    September 25, 2007
    Date of Event
    August 27, 2007
    Report Date
    September 25, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCOUNT HAS BEEN EXPERIENCING INTERMITTENT DISCREPANT SODIUM RESULTS SINCE MAY. THEY GAVE THE FOLLOWING PATIENT RESULTS AS EXAMPLES (SAMPLE #, DATE, INITIAL/REPEAT MEQ/L): SAMPLE 1, 8/27-124/130, SAMPLE 2, 8/27-133/140, SAMPLE 3, 8/28-127/133, SAMPLE 4, 8/31-124/130, SAMPLE 5, 9/4-129/136, SAMPLE 6, 9/5-134/140. THE INCORRECT RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANT RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA