BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1000536 · Received February 15, 2008

    Report

    Report Number
    1823260-2008-01597
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 21, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    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 WITH DISCREPANT TROPONIN T RESULTS. INITIAL RESULT GAVE 0.122 UG/L; REPEATED TWICE GIVING 0.016 AND 0.019 UG/L. 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 MMI ROCHE DIAGNOSTICS 2010 RACK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK