BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1193376 · Received October 7, 2008

    Report

    Report Number
    1823260-2008-07401
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 15, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED DISCREPANT URIC ACID RESULTS FOR ONE PATIENT SAMPLE. INITIAL RESULT GAVE 0 MG/DL; REPEATED TWICE GAVE 4.9 AND 4.8 MG/DL. THE ORIGINAL RESULT WAS NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE A BROKEN LIQUID LEVEL DETECTION CABLE, AND REPLACED CABLE. 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 86 YR