BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL 25 TEST

    MDR report key: 1942315 · Received December 22, 2010

    Report

    Report Number
    2027969-2010-02256
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 28, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED A POTENTIAL FALSE NEGATIVE TROPONIN (TNI) RESULT USING THE TRIAGE CARDIAC PANEL 25 TEST. PT WAS ADMITTED WITH CHEST PAIN. DIAGNOSIS: CHRONIC RENAL DISEASE. WHOLE BLOOD SAMPLES WERE TESTED FRESH, WITHIN TWO HOURS OF COLLECTION. EDTA TUBE FOR TRIAGE, HEPARIN TUBE FOR BECKMAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PANEL 25 TEST CARDIAC MAKER TEST MMI ALERE SAN DIEGO, INC. 97000HS W47759

    Patients

    Seq Age Sex Outcome Treatment
    1