BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRIAGE PROFILER SOB PANEL

    MDR report key: 1959449 · Received January 5, 2011

    Report

    Report Number
    2027969-2011-00030
    Event Type
    Death
    Date Received
    January 5, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 5, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DDR
    PMA / PMN Number
    K042723
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED FALSE NEGATIVE MYOGLOBIN RESULTS. PT DIED. UNABLE TO DETERMINE CAUSE OF DEATH; DUE TO MEDICAL CODE OF ETHICS, CUSTOMER WOULD NOT SPECIFY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE PROFILER SOB PANEL CARDIAC MARKER TEST DDR ALERE SAN DIEGO, INC. C97300 W47487B

    Patients

    Seq Age Sex Outcome Treatment
    1 Death