BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIOPROFILER TEST

    MDR report key: 2080299 · Received March 31, 2011

    Report

    Report Number
    2027969-2011-00673
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 31, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED POTENTIAL FALSE NEGATIVE TROPONIN I (TNI) RESULTS ON TRIAGE CARDIOPROFILER TEST AT DIFFERENT DRAW TIMES. THE FIRST SAMPLE DRAW WAS ON (B)(6) 2011 AT 8:10 AM IN THE EMERGENCY ROOM AND THE TNI WAS POSITIVE. A TNI RESULT AT 11:20 AM IN THE EMERGENCY ROOM GAVE A NEGATIVE RESULT (BOTH CALLER AND SITE BELIEVE THIS MAY HAVE BEEN A MISRUN OR MISLABELED SAMPLE). A SAMPLE RUN IN THE LAB AT 4:50 PM (ALSO ON TRIAGE TEST) PROVIDED A RESULT THAT WAS IN WHAT THE FACILITY CONSIDERS THE GREY AREA. THIS WAS FOLLOWED BY A SAMPLE RUN AT 8:25 PM AND ONE AT 5:00 AM THE FOLLOWING DAY BOTH RUN IN THE LAB WITH VALUES IN THE GREY AREA. NO PATIENT INFORMATION WAS PROVIDED. FIRST SAMPLES RUN IN EMERGENCY ROOM WITH LOT W48357 AND SECOND SAMPLES RUN IN LAB WITH LOT W48350.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIOPROFILER TEST CARDIAC MARKER TEST MMI ALERE SAN DIEGO, INC. 97100CP W48357

    Patients

    Seq Age Sex Outcome Treatment
    1