BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIA-PACK CTNI 2ND-GEN

    MDR report key: 587877 · Received March 30, 2005

    Report

    Report Number
    2950409-2005-00021
    Event Type
    Other
    Date Received
    March 30, 2005
    Date of Event
    March 9, 2005
    Report Date
    March 29, 2005
    Manufacturer
    TOSOH CORP
    Product Code
    MMI
    Report Source
    Distributor report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DISCREPANT TROPONIN I RESULTS FROM SAME SPECIMEN. "RAN A PT, GOT A POSITIVE TROPONIN OF 1.00, MYO OF 14.9. ALL OTHER CARDIAC MARKERS WERE NEGATIVE SO DECIDED TO JUST RERUN SAME SAMPLE WITH JUST TROPONIN CUP. THE RESULT WAS THEN 0.48. REPORTED THIS ANSWER. THEN DECIDED TO GET A NEW SPECIMEN AND RUN BOTH TROP AND MYO. PT'S RESULTS WERE 0.0 FOR TROP AND 14.1 FOR MYO. ON THE PT'S 6 HOUR SPECIMEN, RESULTS WERE <L FOR TROP, <L FOR MYO. REPORTED THESE OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIA-PACK CTNI 2ND-GEN TROPONIN I IMMUNOASSAY MMI TOSOH CORP NA EZ19342

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other