BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIO PROFILER TEST

    MDR report key: 1120995 · Received August 16, 2008

    Report

    Report Number
    2027969-2008-00011
    Event Type
    Malfunction
    Date Received
    August 16, 2008
    Date of Event
    July 15, 2008
    Report Date
    August 15, 2008
    Manufacturer
    BIOSITE, INCORPORATED
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIFTEEN FRESH WHOLE BLOOD SAMPLES WERE TESTED ON RETURNED DEVICES FROM LOT W42845 AND ON IN-HOUSE RETENTIONS OF LOT W42085 AND WITH THE ACCESS 2 TNI ASSAY. RESULTS WERE AS FOLLOWS: SAMPLE #42 TNI=0.14 ON LOT W42845 AND <0.05 ON LOT W42085 AND ACCESS=0.01. SAMPLE #42 TNI=0.1 ON LOT W42845 AND <0.05 ON LOT W42085 AND ACCESS=0.06 UNABLE TO DETERMINE IF IT WAS A TRUE ELEVATED TNI RESULT. ALL OTHER SAMPLES GAVE NEGATIVE RESULTS WITH BOTH LOTS AND ACCESS ASSAY. CUSTOMER RESULTS WERE ONLY CONFIRMED WITH SAMPLE #42.

    Description of Event or Problem · 1

    CUSTOMER HAD A HIGH INCIDENCE OF ELEVATED TROPONIN I (TNI) RESULTS IN THE RANGE OF 0.13-0.39 NG/ML FOR SPECIMENS THAT HAD CKMB AND MYOGLOBIN RESULTS OR CLINICAL PRESENTATION THAT WAS INCONSISTENT WITH ELEVATED TROPONIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIO PROFILER TEST CARDIAC PANEL TEST MMI BIOSITE, INCORPORATED 97100CP W42845

    Patients

    Seq Age Sex Outcome Treatment
    1