BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL 25 TEST

    MDR report key: 2000518 · Received February 1, 2011

    Report

    Report Number
    2027969-2011-00226
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 10, 2011
    Report Date
    February 1, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED A POTENTIAL FALSE POSITIVE TROPONIN I (TNI) RESULT USING TRIAGE CARDIAC PANEL TEST. AN ER PATIENT'S WHOLE BLOOD SAMPLE RESULTED IN A POSITIVE TNI RESULT. WHEN THE PT WAS REDRAWN THREE HOURS LATER, THE TNI RESULT WAS NEGATIVE. THE FIRST SAMPLE WAS RETESTED WITH A NEGATIVE TNI RESULT. PT WAS NOT ADMITTED TO HOSPITAL AND NO ALTERNATE LAB TESTING WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PANEL 25 TEST CARDIAC MARKET TEST MMI ALERE SAN DIEGO, INC. 97000HS W47798

    Patients

    Seq Age Sex Outcome Treatment
    1