BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB 25 TEST KIT

    MDR report key: 1952408 · Received January 3, 2011

    Report

    Report Number
    2027969-2011-00005
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 13, 2010
    Report Date
    January 3, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    MMI
    PMA / PMN Number
    K042723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED FALSE POSITIVE TROPONIN I (TNI) AND CKMB RESULTS ON ONE PATIENT USING TRIAGE PROFILER SOB TEST. SENIOR NURSE CALLED FROM (B)(6) THAT WAS IN (B)(6) AT THE TIME OF TESTING ON ONE PATIENT. THE PATIENT WAS TESTED AT 12PM ON (B)(6) 2010, WITH NEGATIVE TNI AND CKMB RESULTS. THE PATIENT WAS TREATED AS NON-CARDIAC EVENT WITH NO EVIDENCE OF MI. ANOTHER SAMPLE WAS TAKE AT 5:30 PM WITH POSITIVE TNI AND CKMB. REPEAT OF SAME SAMPLE 30 MINUTES LATER GAVE LOWER POSITIVE RESULTS. ANOTHER SAMPLE WAS DRAWN AND TESTED AT 6AM ON (B)(6) 2010, WHICH HAD A LOWER RESULT THAT THE PREVIOUS DAY. A REPEAT TESTING OF THIS SAMPLE GAVE A SLIGHTLY LOWER POSITIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE PROFILER SOB 25 TEST KIT CARDIAC MARKER TEST MMI ALERE SAN DIEGO, INC 97300 W47520B

    Patients

    Seq Age Sex Outcome Treatment
    1