BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400

    MDR report key: 1054904 · Received May 30, 2008

    Report

    Report Number
    1823260-2008-04392
    Event Type
    Malfunction
    Date Received
    May 30, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 30, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PT WITH DISCREPANT SODIUM RESULTS. INITIAL RESULT IN 2008, 128 MMOL/L. SAME SAMPLE WAS REPEATED ELEVEN TIMES IN THE NEXT DAY, GAVE 134, 130, 129, 135, 135, 131, 130, 134, 129, 130, AND 134 MMOL/L. SAME SAMPLE REPEATED THREE TIMES IN THE NEXT DAY GAVE 137, 138 AND 136 MMOL/L. THE INITIAL RESULT WAS NOT REPORTED. IF ADDITIONAL INFO IS RECEIVED APPROPRIATE NOTIFICATIONS WILL BE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR