BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIAGE CARDIAC PANEL TEST

    MDR report key: 2040196 · Received March 24, 2011

    Report

    Report Number
    2027969-2011-00602
    Event Type
    Other
    Date Received
    March 24, 2011
    Date of Event
    February 22, 2011
    Report Date
    March 24, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED A FALSE POSITIVE TROPONIN I (TNI) RESULT ON TRIAGE CARDIAC PANEL TEST VS. BECKMAN ACCESS2. A (B)(6) FEMALE WENT TO THE EMERGENCY DEPARTMENT WITH CHEST PAINS AND SHORTNESS OF BREATH. SHE WAS ADMITTED (NOT SURE WHETHER PT WAS DISCHARGED AT TIME COMPLAINT WAS CALLED IN). THE FIRST DRAW WAS ON (B)(6) 2011 AT 9:30 AM WITH A POSITIVE TNI RESULT OF TRIAGE. A CARDIAC CATH WAS DONE. THE SECOND DRAW WAS ON (B)(6) 2011 AT 4:00 AM AND WAS RUN ON THE BECKMAN ACCESS2 WITH A NEGATIVE RESULT. METABOLIC ASSAYS (LAB WORK) WERE 'OK'. EKG - UNKNOWN.

    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 W48723

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| O