BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800 ANALYZER

    MDR report key: 1083371 · Received July 28, 2008

    Report

    Report Number
    1823260-2008-05823
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 17, 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
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    TWO DISCREPANT SODIUM RESULTS. PT 1 INITIAL RESULT 128 MMOL/L, REPEAT 140 MMOL/L. ERRONEOUS RESULTS WERE NOT REPORTED. FIELD SERVICE REP DETERMINED ROOT CAUSE TO BE A PROBLEM WITH THE WASTE VALVE ON THE ISE MODULE AND REPAIRED THE VALVE. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 2

    TWO DISCREPANT SODIUM RESULTS. INITIAL RESULT 129 MMOL/L, REPEAT 138 MMOL/L. ERRONEOUS RESULTS WERE NOT REPORTED. FIELD SERVICE REP DETERMINED ROOT CAUSE TO BE A PROBLEM WITH THE WASTE VALVE ON THE ISE MODULE AND REPAIRED THE VALVE. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1
    2 UNK