BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE CARDIAC PROFILER KIT

    MDR report key: 1997515 · Received February 9, 2011

    Report

    Report Number
    2027969-2011-00289
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 18, 2011
    Report Date
    February 9, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SUPPORT COULD NOT RULE OUT SAMPLE SPECIFIC INTERFERENCE WITHOUT RETURN OF PT SAMPLE. PROFILER LOT W48339 HAS BEEN PREVIOUSLY TESTED. NO DISCREPANT RESULTS WERE OBSERVED WITH RETAIN DEVICES. CONCLUSION: PRODUCT SUPPORT TESTED IN HOUSE CAL H(POS CTRL) AND CAL Z (NEG CTRL) ON RETAIN LOT #W48339. RESULTS FOR TNI RECOVERY ARE BELOW: CAL H: ALL 3 REPLICATES TNI RESULTS WERE WITHIN THE MFG 1SD RANGE. CAL Z: PRODUCT SUPPORT OBSERVED ALL DATA POINTS FOR CAL Z TO BE BELOW THE MFG CUT OFF OF 0.10NG/ML. UNABLE TO DETERMINE CAUSE OF CUSTOMERS POSITIVE RESULT WITHOUT SAMPLE. NO PRODUCT DEFICIENCY WAS ESTABLISHED. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER REPORTED A FALSE POSITIVE TROPONIN (TNI) RESULT USING THE TRIAGE CARDIAC PROFILER. PT WENT TO THE ED COMPLAINING OF CHEST PAINS. PT WAS ADMITTED AND LATER DISCHARGED. DIAGNOSIS: RHABDOMYOLYSIS, ACUTE BRONCHITIS. TRIAGE TNI CUT OFF: 0-0.4. DIMENSION LAB ANALYZER: 0-0.5. SERIAL DRAWS WERE TESTED ON LAB ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PROFILER KIT CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97100CP W48339

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization