BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2010 RACK ELECSYS RET

    MDR report key: 975705 · Received January 7, 2008

    Report

    Report Number
    1823260-2008-00190
    Event Type
    Malfunction
    Date Received
    January 7, 2008
    Date of Event
    December 18, 2007
    Report Date
    January 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER REPORTS GETTING DISCREPANT TROPONIN T RESULTS FOR THREE PT SAMPLES. ONLY ONE EXAMPLE WAS PROVIDED. SAME SAMPLE USED FOR REPEAT TESTING ON SAME ANALYZER. INITIAL TROPONIN T RESULT GAVE 0.012 NG/ML; SAMPLE REPEATED TWO TIMES GIVING 0.439 NG/ML EACH TIME. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE THE CAUSE FOR THE DISCREPANCY. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2010 RACK ELECSYS RET IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS E2010 RACK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK