BEUDAMED
    FDA Adverse Event Death Summary report: N

    MTX

    MDR report key: 496249 · Received November 18, 2003

    Report

    Report Number
    1039284-2003-00011
    Event Type
    Death
    Date Received
    November 18, 2003
    Date of Event
    August 4, 2003
    Report Date
    November 12, 2003
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    GKP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE MTX INSTRUMENT RAN A PT TEST. THE RESULT ON THE MTX SCREEN SHOWED "NO CLOT". THE CODE WHICH CORRESPONDS TO "NO CLOT" FOR THE MTX IS 01. THIS WAS TRANSMITTED ACROSS THE LIS IN THE LAB AS 0.00 SECONDS AND THE LAB TECH REPORTED THE PROTIME/INR AS >6. THE PT WAS IN THE HOSPITAL BEFORE THE TEST IN CRITICAL CONDITION. THE PT WAS TRANSFERRED TO CRITICAL CARE AT ANOTHER HOSPITAL AFTER THE RESULT WAS GIVEN. THE NEW HOSPITAL RERAN THE TEST AND GOT NO CLOT RESULT. THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTX MULTIPURPOSE FOR IN-VITRO COAGULATION STUDIES GKP BIOMERIEUX, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death