BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1053006 · Received May 27, 2008

    Report

    Report Number
    1823260-2008-04304
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE FEMALE PATIENT WITH DISCREPANT HCG RESULT. INITIAL RESULT REPORTED, PATIENT NOT ADVERSELY AFFECTED. INITIAL RESULT 14.37 IU/ML, SAME SAMPLE REPEATED NEGATIVE ON SCREENING TEST (ALTERNATE METHODOLOGY), SAME SAMPLE REPEATED <0.500 IS/ML AGAIN ON ORIGINAL ANALYZER. FIELD SERVICE REP UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOASSAY ANALYZER DHA ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR