BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1234079 · Received November 4, 2008

    Report

    Report Number
    1823260-2008-08154
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 15, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCING ON-GOING ISSUE WITH DISCREPANT SODIUM RESULTS. ONE PT EXAMPLE WAS PROVIDED, INITIAL RESULT GAVE 129 MEQ/L. SAME SAMPLE REPEATED THREE TIMES GAVE 137.5 MEQ/L (DIFFERENT METHODOLOGY), 135 AND 134 MEQ/L. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN. PT WAS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TEST WERE PERFORMED.

    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 UNK