BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 DISK

    MDR report key: 1002621 · Received February 8, 2008

    Report

    Report Number
    1823260-2008-01345
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 15, 2008
    Report Date
    February 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PT WITH DISCREPANT TROPONIN T RESULTS. INITIAL RESULT GAVE >0.01 NG/ML, SAMPLE REPEATED THREE TIMES GIVING 0.096, 0.080, AND 0.077 NG/ML RESPECTIVELY. ERRONEOUS RESULT WAS REPORTED. PT NOT ADVERSELY AFFECTED. THE FIELD SERVICE REP FOUND THE S/R PROBE TO BE MISALIGNED AND REALIGNED THE S/R PROBE. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK