BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL TEST

    MDR report key: 1813172 · Received August 18, 2010

    Report

    Report Number
    2027969-2010-01234
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 18, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED FALSE POSITIVE TROPONIN I (TNI) RESULTS ON TRIAGE CARDIAC PANEL TEST VS ACCESS. A (B)(6) FEMALE CAME TO ED IN THE EVENING COMPLAINING OF CHEST PAIN, SHORTNESS OF BREATH, HEADACHE, DIZZINESS AND HEART PALPITATIONS. INITIAL TROPONIN I RESULTS RUN ON TRIAGE WERE POSITIVE (PINK METER). THEY ALSO RAN A SAMPLE ON ACCESS WITH THIS SPECIMEN WITH NEGATIVE RESULTS. ANOTHER SPECIMEN WAS COLLECTED 75 MINUTES LATER WITH POSITIVE TNI RESULTS ON TRIAGE METER (PINK METER). PT SENT HOME BY ER DOCTOR.

    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 W47051B

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR