BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1070022 · Received July 3, 2008

    Report

    Report Number
    1823260-2008-05193
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 10, 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
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT WITH DISCREPANT GLUCOSE RESULTS. INITIAL RESULT GAVE 3 MG/DL. SAME SAMPLE REPEATED THREE TIMES GIVING 2, 6 AND 110 MG/DL. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED A PROBLEM WITH THE FLUIDICS SYSTEM TO BE THE CAUSE AND REPLACED BOTH SAMPLE PROBES AND BOTH WASH PROBE SEALS. HE ALSO NOTED HE REPLACED THE DEGASSER AND WATER LINE FILTER. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I400+

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK