BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLASTIN HTF

    MDR report key: 372668 · Received January 16, 2002

    Report

    Report Number
    1039284-2002-00001
    Event Type
    Injury
    Date Received
    January 16, 2002
    Date of Event
    January 5, 2002
    Report Date
    January 14, 2002
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    GJS
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2002 PATIENT WAS ADMITTED TO ER WITH ACTIVE NOSEBLEED. THIS PATIENT WAS IDENTIFIED AS BEING ON LONG TERM WARFARIN THERAPY. SAMPLES OF BLOOD WERE DRAWN FOR INR AND FBC TESTING. INR DETERMINED ON MDA AN REPORTED AS 1.1(PT = 12.3 SECONDS). WARFARIN DOSE WAS ADMINISTERED ON THIS EVENING BUT REDUCED FROM 6.5MG TO 5.0MG. THE PATIENT WAS ADMITTED INTO THE HOSPITAL AS AN IN-PATIENT. THE PATIENT'S NOSE CONTINUED TO BLEED THROUGHOUT THE NIGHT. THE NEXT DAY SAMPLES OF BLOOD WERE DRAWN FOR RETEST. INR FOUND TO BE 21.8. SAMPLE WAS REPEATED ALONG WITH FBC. INR RESULT 22.2 AND HEMOGLOBIN LEVEL WAS +/-6.0G/DL. ORIGINAL SAMPLE WAS RETESTED ON THE MDA AND WAS DETERMINED AS "NO CLOT". INR = 9.9 (TESTED ON ACL INSTRUMENT WITH/SIMPLASTIN HTF). VINTAMIN K ADMINISTERED TO THE PATIENT ALONG WITH 2 UNITS OF BLOOD TO CONTROL BLEEDING. NO WARFARIN HAS BEEN ADMINISTERED SINCE DAY OF ADMISSION AS OF 6 DAYS AFTER EVENT DATE, PATIENT REMAINS IN HOSPITAL BUT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLASTIN HTF PROTHROMBIN TIME TEST GJS BIOMERIEUX, INC. NA 161560

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization