BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIA ST-CTNI 2ND GEN

    MDR report key: 2852928 · Received November 7, 2012

    Report

    Report Number
    3005529799-2012-00016
    Event Type
    Other
    Date Received
    November 7, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 7, 2012
    Manufacturer
    TOSOH AIA, INC.
    Product Code
    MMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A TROPONIN ASSAY WAS DONE AND QC RESULTS WERE WITHIN ACCEPTABLE TARGET RANGE, SO RESULTS WERE REPORTED. ONE PT HAD A POSITIVE RESULT FOR THE TROPONIN AND WAS SENT TO THE HOSPITAL FOR FURTHER EVALUATION, BUT WAS NOT TREATED FOR AMI. A TROPONIN RESULT AT THE HOSPITAL WAS NEGATIVE. THE INITIAL SPECIMEN WAS REPEATED AND THE REPEAT RESULT WAS NEGATIVE. ROOT CAUSE: UNIDENTIFIED THROUGH INVESTIGATION, ALTHOUGH FIBRIN CLOT IS SUSPECTED TO HAVE INTERFERED WITH FIRST (FALSE POSITIVE) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIA ST-CTNI 2ND GEN TROPONIN MMI TOSOH AIA, INC. NA C319310

    Patients

    Seq Age Sex Outcome Treatment
    1 Other