BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIOPROFILER KIT

    MDR report key: 2428707 · Received December 23, 2011

    Report

    Report Number
    2027969-2011-02612
    Event Type
    Malfunction
    Date Received
    December 23, 2011
    Date of Event
    December 15, 2011
    Report Date
    December 23, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED POTENTIAL FALSE POSITIVE RESULTS ON TRIAGE TROPONIN I (TNI) WHEN TESTING BOTH TRIAGE CARDIOPROFILER AND TRIAGE PROFILER SOB TESTS. IT WAS NOT CLEAR WHICH RESULT WAS OBTAINED FROM WHICH TRIAGE DEVICE. A SEPARATE MEDWATCH REPORT IS BEING SUBMITTED FOR EACH OF THE PRODUCTS: THIS REPORT FOR THE TRIAGE CARDIOPROFILER TEST AND MEDWATCH REPORT #2027969-2011-02613 FOR THE PROFILER SOB TEST. CUSTOMER MENTIONED GETTING LOW LEVEL TROPONIN RESULTS ON DIFFERENT PTS USING PROFILER AND SOB PANELS. CUSTOMER ASKED WHAT COULD POTENTIALLY CAUSE THE LOW LEVEL TNI. TECHNICAL SERVICE REP DISCUSSED THE FOLLOWING: MAKE SURE THE FULL AMOUNT OF SAMPLE IS ADDED TO THE WELL AND MAKE SURE IT FULLY ABSORBS INTO THE DEVICE PRIOR TO INSERTION INTO THE METER. THE CALLER SAID THE TECH MENTIONED THE SAMPLES DID TAKE A WHILE TO ABSORB. SHE WILL OBSERVE STAFF AND LET THEM KNOW TO LET SAMPLES ABSORB INTO THE DEVICE. SHE WILL MONITOR AND CALL BACK IF ISSUE PERSISTS. NO PT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIOPROFILER KIT CARDIAC MARKER TEST MMI ALERE SAN DIEGO, INC. 97100CP W49597B

    Patients

    Seq Age Sex Outcome Treatment
    1