BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEHRING FIBRINTIMER A

    MDR report key: 129659 · Received July 1, 1997

    Report

    Report Number
    129659
    Event Type
    Injury
    Date Received
    July 1, 1997
    Date of Event
    May 19, 1996
    Report Date
    June 17, 1996
    Manufacturer
    BEHRING DIAGNOSTIC, INC.
    Product Code
    GKT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT CAME INTO ER AT 1900 WITH CHEST PAIN AND HYPOXIA DYSPNEA, PNEUMONIA, SUSPECTED PULMONARY EMBOLISM, ADMITTED FOR OBSERVATION IN THE CORONARY CARE UNIT. HEPARIN WAS NOT STARTED. PTT WAS REPORTED AT 78.2 FOR BASELINE LAB DRAW. PT EXPIRED THE NEXT AM, 5/20/96.

    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 46 YR Required Intervention