BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL 25 TEST

    MDR report key: 1903036 · Received November 12, 2010

    Report

    Report Number
    2027969-2010-01943
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 9, 2010
    Report Date
    November 12, 2010
    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
    OTHER

    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. TRIAGE RESULTS: EDTA WHOLE BLOOD. DATE: (B)(6) 2010, TIME: 15:39, CK-MB: 4.1, MYO: 237, TNI: <0.05. DATE: (B)(6) 2010, TIME: 17:35, CK-MB: 4.8, MYO: 287, TNI: 0.07. DATA: (B)(6) 2010, TIME: 8:30 AM, CK-MB: 1.4, MYO: 158, TNI: <0.05.

    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 W47714B

    Patients

    Seq Age Sex Outcome Treatment
    1