BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRIAGE CARDIAC PROFILER

    MDR report key: 1942080 · Received December 22, 2010

    Report

    Report Number
    2027969-2010-02250
    Event Type
    Death
    Date Received
    December 22, 2010
    Date of Event
    November 24, 2010
    Report Date
    December 23, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. CALLER REPORTS PATIENT PRESENTED IN ER WITH NO INITIAL DIAGNOSIS. CALLER RELATES PATIENT MAY HAVE BEEN EXPERIENCING RENAL DYSFUNCTION. BUN AND CREATINE LEVELS WERE VERY HIGH. HEMOGLOBIN WAS 18G. NO OTHER DISCREPANT RESULTS HAVE BEEN NOTED AT SITE. PATIENT PASSED AWAY WHILE UNDER PHYSICAL CARE, CAUSE OF DEATH WAS NOT PROVIDED. PHYSICIANS ACTED UPON BECKMAN RESULTS. NO SAMPLE IS REMAINING FOR INVESTIGATION. NO DEVIATIONS IN SAMPLE TECHNIQUE PER PRODUCT INSERT. TEST DEVICES WERE RUN AT ROOM TEMPERATURE. CONTROLS ARE WITHIN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PROFILER CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC 97100CP W47997

    Patients

    Seq Age Sex Outcome Treatment
    1 Death