BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    917 DISK SYSTEM

    MDR report key: 1051422 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04202
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THREE SAMPLES WITH DISCREPANT HEMOGLOBIN RESULTS, AS PART OF HEMOGLOBIN A1C ASSAY. SAMPLE 1, INITIAL RESULT 10.5 G/DL, REPEAT 14.0 G/DL. SAMPLE 2, INITIAL RESULT 11.8 G/DL, REPEAT 14.9 G/DL. SAMPLE 3, INITIAL RESULT 14.5 G/DL, REPEAT 18.2 G/DL. NO RESULTS WERE REPORTED SINCE THE HEMOGLOBIN RESULT IS ONLY ONE PORTION OF THE HEMOGLOBIN A1C ASSAY. THE FIELD SERVICE REP DETERMINED INCORRECT PLACEMENT OF THE CELL DETERGENT 1 TUBING TO BE THE CAUSE AND HE ADJUSTED THE TUBING. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 917 DISK SYSTEM CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS 917

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK