BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 DISK

    MDR report key: 1133411 · Received August 22, 2008

    Report

    Report Number
    1823260-2008-06366
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 25, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OPERATOR RECEIVED DISCREPANT HCG RESULTS FOR ONE PATIENT. INITIAL RESULT <5 MLU/ML, REPEAT 1553 MLU/ML. THE INITIAL RESULT WAS REPORTED. THE PATIENT WAS GIVEN AN UNSPECIFIED MEDICATION BASED ON THE RESULT. THE MEDICATION WAS PROVIDED TO CAUSE MENSTRUATION. PER THE LABORATORY SUPERVISOR, THERE WAS NO UNFAVORABLE OUTCOME ASSOCIATED WITH THE ERRONEOUS RESULT. THE FIELD SERVICE REP DETERMINED SAMPLE AND REAGENT WHEEL ALIGNMENTS TO BE THE CAUSE AND HE PERFORMED ALL SAMPLE, REAGENT WHEEL AND SIPPER ALIGNMENTS. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 DISK IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS 2010 DISK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR