BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL TEST

    MDR report key: 1935642 · Received December 15, 2010

    Report

    Report Number
    2027969-2010-02184
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    November 14, 2010
    Report Date
    December 15, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POTENTIAL FALSE POSITIVE TROPONIN I (TNI) RESULT ON TRIAGE CARDIAC PANEL. NO DATA AND NO PT INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PANEL TEST CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC 97000HS W47765

    Patients

    Seq Age Sex Outcome Treatment
    1