BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE CARDIC PROFILER TEST

    MDR report key: 1343247 · Received March 10, 2009

    Report

    Report Number
    2027969-2009-00104
    Event Type
    Injury
    Date Received
    March 10, 2009
    Date of Event
    February 23, 2009
    Report Date
    March 9, 2009
    Manufacturer
    BIOSITE INC.
    Product Code
    MMI
    PMA / PMN Number
    030286
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING CONDUCTED IN 2009: QCR PROFILER AND DONOR WHOLE BLOOD SAMPLE. TESTING RESULTS THE SAME DAY: PRODUCT SUPPORT OBSERVATIONS FOR TNI RECOVERY WITH TESTING ON (QC RETAIN), QC RETAIN CAL Z AND DONOR WHOLE BLOOD SAMPLE. NO ERROR CODES OR STANDARD OUTLIERS WERE OBSERVED. OF THE 5 REPS RUN WITH CAL Z, ALL DATA POINTS WERE BELOW THE THRESHOLD OF <0.05. OF THE 5 REPS RUN WITH THE DONOR WB, ALL DATA POINT WERE BELOW THE THRESHOLD OF <0.05. NO FALSE POSITIVES OR ELEVATED LEVELS WERE OBSERVED. TESTING CONDUCTED THE FOLLOWING MONTH: QCR PROFILER. CM CAL G AND RETURNED PT SAMPLE. TESTING FOR HAMA ANTIBODY INTERFERENCE WAS ALSO PERFORMED. PRODUCT SUPPORT TESTING RESULTS FROM THAT DAY: TNI RESULTS: TRAIGE 0.07, TRAIGE+ HAMA <0.05, ACCESS II 0.02. NO FALSE POSITIVES OR ELEVATED VALUES WERE OBSERVED. NO DISCREPANCIES BETWEEN TRAIGE AND ACCESS II RESULTS. HAMA TESTING DID NOT RESULT IN A SIGNIFICANT CHANGE IN ANALYTE RECOVERY. NO CORRECTIVE ACTION REQUIRED AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER REPORTED POSSIBLE FALSE POSITIVE ON TRIAGE PROFILER TROPONIN I (TNI) TEST. WHOLE BLOOD SAMPLE TESTED ON PROFILER LOT # W43351 GAVE A TNI RESULT OF 8.0 IN 2009. PT TRANSFERRED TO ANOTHER HOSPITAL WHERE TNI WAS NEGATIVE (CALLER THINKS METHOD WAS ACCESS). THREE DAYS LATER, CALLER TESTED ANOTHER LAVENDER TOP THAT WAS DRAWN AT THE SAME TIME AS THE ORIGINAL DATE SAMPLE THAT GAVE 8.0 TNI ON PROFILER. RETESTING RESULTS: WHOLE BLOOD 5.03 AND PLASMA <0.05.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIC PROFILER TEST CARDIAC MARKER TEST MMI BIOSITE INC. 97100CP W43351

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization