BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MDA ANTITHROMBIN III

    MDR report key: 527411 · Received May 27, 2004

    Report

    Report Number
    3002769706-2004-00006
    Event Type
    Injury
    Date Received
    May 27, 2004
    Date of Event
    April 23, 2004
    Report Date
    May 21, 2004
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JPE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED TO ASK ABOUT RESULTS GIVEN WITH THE MDA ANTITHROMBIN III REAGENT (MDA ATIII). THE CUSTOMER REPORTED THAT THEY HAD QUESTIONABLY LOW RESULTS. THE CUSTOMER WAS ADVISED TO RUN WITH THE CAPS OFF RATHER THAN IN CAP PIERCING MODE. THE RESULTS WERE HIGHER AND CLOSER TO EXPECTED VALUES. THE CUSTOMER FAXED IN THE DATA WHICH SHOWED A MARKED DIFFERENCE IN RESULTS BETWEEN "CAPS ON" AND "CAPS OFF." THE CUSTOMER REPORTED THAT TWO PTS WERE PLACED ON COUMADIN BASED ON THE RESULTS WITH THE CAPS ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MDA ANTITHROMBIN III CLASS II, 864.7060 ANTITHROMBIN III ASSAY JPE BIOMERIEUX, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention