BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1213186 · Received October 23, 2008

    Report

    Report Number
    1823260-2008-07859
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    October 4, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT TROPONIN T RESULT FOR ONE PATIENT SAMPLE. INITIAL RESULT 0.114 MG/ML, REPEATED AT <0.010 MG/ML TWICE. NO INFORMATION WAS PROVIDED TO DETERMINE IF INITIAL RESULT WAS REPORTED OR IF ANY ADVERSE EVENTS OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED, 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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK