BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE CARDIAC PANEL 25 TEST

    MDR report key: 1902526 · Received November 12, 2010

    Report

    Report Number
    2027969-2010-01940
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED, A FALSE POSITIVE TROPONIN (TNI) RESULT USING THE TRIAGE CARDIAC PANEL 25 TEST. PT WAS ADMITTED ON CHEST PAIN. DIAGNOSIS IS PENDING CARDIAC CATHETER. TNI CUT-OFF 0.4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PANEL 25 TEST CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC 97000HS W47736

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization