BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1001787 · Received February 19, 2008

    Report

    Report Number
    1823260-2008-01694
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 24, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT SAMPLE WITH DISCREPANT HCG RESULTS. INITIAL RESULT 13.69 MIU/ML. SAME SAMPLE REPEATED USING DIFFERENT INSTRUMENT, SAME METHOD, GAVE RESULT OF 0.100 MIU/ML. SAMPLE REPEATED AGAIN USING INITIAL METHOD, GAVE RESULT OF 0.124 MIU/ML. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANCY. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK