BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXSYM COCAINE METABOLITE

    MDR report key: 476832 · Received August 5, 2003

    Report

    Report Number
    2623532-2003-00004
    Event Type
    Death
    Date Received
    August 5, 2003
    Report Date
    August 1, 2003
    Manufacturer
    ABBOTT HEALTH PRODUCTS, INC.
    Product Code
    DIO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A URINE SAMPLE FROM A PT WAS COLLECTED IN THE E.R. AND TESTED FOR COCAINE ON THE AXSYM ANALYZER AT A SISTER FACILITY. THE AXSYM COCAINE METABOLITE RESULT GENERATED WAS 325NG/ML (300NG/ML CUT-OFF) AND WAS REPORTED AS POSITIVE. AN ALIQUOT OF THE SAMPLE WAS SENT TO A REFERENCE LABORATORY FOR CONFIRMATION WHERE IT TESTED NEGATIVE FOR COCAINE (<25NG/ML) AND COCAINE METABOLITES USING GC/MS METHOD. THE CUSTOMER STATES THAT THE PT DIED IN THE E.R. THE DATES OF THE EVENTS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM COCAINE METABOLITE FPIA FOR DETECTION OF COCAINE METABOLITE DIO ABBOTT HEALTH PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death AXSYM ANALYZER LIST NO. 7A83-01.