BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1022204 · Received March 26, 2008

    Report

    Report Number
    1823260-2008-02813
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    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 CKMB RESULTS. INITIAL RESULT GAVE 8.27 NG/ML. SAMPLE REPEATED TWICE GIVING 2.37 AND 2.22 NG/ML RESPECTIVELY. ERRONEOUS RESULT WAS REPORTED. PATIENT NOT ADVERSELY AFFECTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE ROOT CAUSE. 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 JJE ROCHE DIAGNOSTICS 2010 RACK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK