BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1003419 · Received February 21, 2008

    Report

    Report Number
    1823260-2008-01739
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH DISCREPANT TROPONIN T RESULTS. INITIAL RESULT GAVE 0.194 NG/ML. SAME SAMPLE REPEATED TWICE GAVE RESULTS OF 0.012 NG/ML EACH TIME. NO INFO PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. IF ADD'L INFO IS REC'D, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    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