BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1052525 · Received May 22, 2008

    Report

    Report Number
    1823260-2008-04260
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 26, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT WITH DISCREPANT GLUCOSE RESULTS INITIAL RESULT REPORTED, PATIENT NOT ADVERSELY AFFECTED. INITIAL RESULT 328 MG/DL, REPEATED TWICE BOTH RESULTS GIVING 118 MG/DL. FIELD SERVICE REP UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK