BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1070026 · Received July 3, 2008

    Report

    Report Number
    1823260-2008-05197
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 12, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PT WITH DISCREPANT POTASSIUM RESULTS. INITIAL RESULT 5.4 MEG/L, REPEAT 4.6 MEG/L. INITIAL RESULT WAS NOT REPORTED. FIELD SVC REP WAS UNABLE TO DETERMINE ROOT CAUSE, BUT NOTED HE REPLACED PCB ISE PREAMPLIFIER AND ISE TUBING. 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