BEUDAMED
    FDA Adverse Event Summary report: N

    TRIAGE CARDIAC PROFILER KIT

    MDR report key: 2100670 · Received May 11, 2011

    Report

    Report Number
    2027969-2011-01061
    Date Received
    May 11, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 11, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SUPPORT PREVIOUSLY TESTED LOT W48663. TESTING WAS CONDUCTED WITH CALIBRATOR Z (NEGATIVE CONTROL), CALIBRATOR H (POSITIVE CONTROL), AND 2 NORMAL WHOLE BLOOD DONORS. NO HIGH BIAS, ELEVATED VALUES OR FALSE POSITIVES WERE OBSERVED. ALL DATA POINTS PROVIDED BY CUSTOMER FOR TNI, CKMB AND MYO WERE BELOW THE CLINICAL CUTOFF'S AS STATED IN THE PACKAGE INSERT AND DO NOT REPRESENT A FALSE POSITIVE. NO LOT NUMBER GIVEN FOR CARDIO 2 LOT TO PERFORM TESTING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    AN ELDERLY WOMAN HAD AN ACUTE MYOCARDIAL INFARCTION ON (B)(6) 2011. THE MORNING OF (B)(6) SHE PRESENTED AT EMERGENCY DEPT WITH CHEST PAIN. THE PT WAS CLINICALLY UNCERTAIN, ECG WAS NOT DIAGNOSTIC. THE PT WAS INCORRECTLY TREATED AS HAVING ACUTE MYOCARDIAL INFARCTION ACCORDING TO TRIAGE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PROFILER KIT CARDIAC MAKER TEST MMI ALERE SAN DIEGO, INC. 97000HS W48663

    Patients

    Seq Age Sex Outcome Treatment
    1