BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1083373 · Received July 28, 2008

    Report

    Report Number
    1823260-2008-05825
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH DISCREPANT GLUCOSE RESULTS. INITIAL RESULT GAVE 158 MG/DL; REPEATED TWICE GIVING 95 AND 101 MG/DL. ERRONEOUS RESULT WAS NOT REPORTED. THE FIELD SERVICE REP DETERMINED THE CAUSE TO BE A PROBLEM WITH THE PROBE WASH SYRINGE B AND REPLACED SYRINGE. PERFORMANCE TESTS WERE PERFORMED AND 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