BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1011350 · Received March 11, 2008

    Report

    Report Number
    1823260-2008-02288
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 16, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    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

    USER REPORTS RECEIVING MANY DISCREPANT PT RESULTS. ONLY ONE EXAMPLE PROVIDED: INITIAL SODIUM RESULT 117 MMOL/L, REPEAT 132 MMOL/L; INITIAL POTASSIUM RESULT 3.8 MMOL/L, REPEAT 4.4 MMOL/L; INITIAL CALCIUM RESULT 6.7 MG/DL, REPEAT 9.5 MG/DL. INITIAL RESULTS NOT REPORTED. THE FIELD SERVICE REP DETERMINED A BROKEN PROBE TO BE THE CAUSE. THE USER REPLACED THE PROBE. THE FIELD SERVICE REP CHECKED PROBE ALIGNMENT, LIQUID LEVEL DETECTION CABLES AND MECHANICAL BLOCKAGES. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPEC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK