BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL 25 TEST

    MDR report key: 1873698 · Received October 13, 2010

    Report

    Report Number
    2027969-2010-01710
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTS A FALSE NEGATIVE TROPONIN (TNI) RESULT USING THE TRIAGE CARDIAC PANEL 25 TEST. THE CRITICAL CUTOFF FOR TNI IS 0.5. PT WAS ADMITTED TO THE ICU WITH CHEST PAIN AND HYPOXIA. DIAGNOSIS IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PANEL 25 TEST CARDIAC MARKER TEST MMI ALERE SAN DIEGO, INC. 97000HS W47683B

    Patients

    Seq Age Sex Outcome Treatment
    1