BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEHRING FIBRINTIMER A

    MDR report key: 129681 · Received July 1, 1997

    Report

    Report Number
    129681
    Event Type
    Injury
    Date Received
    July 1, 1997
    Date of Event
    May 19, 1996
    Report Date
    June 18, 1996
    Manufacturer
    BEHRING DIAGNOSTIC, INC.
    Product Code
    GKT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT POST CORONARY ANGIOPLASTY AND ON HEPARIN IV THERAPY. IN FOLLOW UP TO THIS, BLOOD WORK WAS DRAWN, A PTT LEVEL AT 1530. LEVEL REPORTED AS 110.2 SECONDS. HEPARIN IV WAS TURNED OFF. LAB PTT REPEATED AT 2042 AND REPORTED AS GREATER THAN 160 SECONDS. CORRECTED LAB VALUES WERE REPORTED AS 6819 AND 5512. HEPARIN WAS RESUMED WHEN CORRECT RESULTS REPORTED. PT DID WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEHRING FIBRINTIMER A COAGULATION INSTRUMENT GKT BEHRING DIAGNOSTIC, INC. * *
    2 REAGENT PATHROMPTIN REAGENT GIT BEHRING DIAGNOSTIC, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention