BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PROFILER KIT

    MDR report key: 2534647 · Received April 5, 2011

    Report

    Report Number
    2027969-2012-00469
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    December 1, 2011
    Report Date
    April 5, 2012
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    MMI
    PMA / PMN Number
    030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 TROPONIN (TNI) ON THE TRIAGE CARDIAC PROFILER VERSUS THE RXL DEVICE. IN (B)(6) 2011, 40 CASES HAD TROPONIN (TNI) IN THE RANGE OF 0.05 - 0.07 ON THE TRIAGE METER; ABOUT HALF OF THESE TESTED <0.05 ON RXL AND THE OTHER HALF AGREED TO THE TRIAGE RESULTS. RECENTLY, CUSTOMER NOTED THAT 21 OUT OF 23 CASES RESULTING IN TNI 0.05 - 0.07 ON THE TRIAGE DEVICE, WERE <0.05 ON THE RXL, AND THE OTHER 2 AGREED WITH THE TRIAGE RESULTS. NO PT INFO PROVIDED. CUT-OFF FOR TNI: TRIAGE = 0.4; GREY-ZONE = 0.05 - 0.04; RXL = 0.05. ALL SAMPLES WERE COLLECTED IN FULL EDTA TUBE. NO CLOTS OR BUBBLES RECORDED. ALL SAMPLES WERE TESTED AS FRESH, LOADED TO DEVICE WITH TRIAGE PIPETTE. ROOM TEMP WAS 72F AND STABLE. TEST DEVICE STORED IN THE FRIDGE, WARMED TO ROOM TEMP FOR HOURS, AND OPENED ONLY AT TEST TIME. THERE'S NO OTHER EQUIPMENT CLOSE TO THE METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PROFILER KIT CARDIAC MARKER PANEL MMI ALERE SAN DIEGO INC 97100CP W49625

    Patients

    Seq Age Sex Outcome Treatment
    1 NI