BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEHRING FIBRINTIMER A

    MDR report key: 129647 · Received July 1, 1997

    Report

    Report Number
    129647
    Event Type
    Injury
    Date Received
    July 1, 1997
    Date of Event
    May 19, 1996
    Report Date
    June 18, 1996
    Manufacturer
    BEHRING DIAGNOSTICS, 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 PRESENTED TO THE ER WITH CHEST PAIN UNRELIEVED AT HOME WITH NTG. SHE RECEIVED A BOLUS DOSE OF HEPARIN IN ER AT 10:30 AM AND AN IV OF HEPARIN AT 1000 U/HR. FOLLOW UP PTT LEVEL AT 1714 WAS REPORTED INCORRECTLY AND HEPARIN WAS ADJUSTED BASED ON INCORRECT LAB VALUE. PT DISCHARGED 5/22/96.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention