BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1061956 · Received June 16, 2008

    Report

    Report Number
    1823260-2008-04754
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH DISCREPANT SODIUM RESULTS. PT 1, A MALE, INITIAL RESULT 128 MMOL/L, REPEAT 137 MMOL/L. THE INITIAL RESULT WAS REPORTED, PT WAS NOT ADVERSELY AFFECTED. THE FIELD SVC REP WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANCY. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    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 76 YR