BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BFA

    MDR report key: 129655 · Received July 1, 1997

    Report

    Report Number
    129655
    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 ADMITTED WITH ANGINA OF 20 TO 30 MINUTE DURATION. UNRELIEVED IN THE ER A BOLUS DOSE OF HEPARIN AND AN IV OF HEPARIN AT 1000 U/HR. FOLLOW-UP TO THIS WAS A PTT LEVEL ORDERED FOR 2200. LAB RESULTS REPORTED INCORRECT DUE TO STIRRING ARM IN EQUIPMENT TO KEEP REAGENT SUSPENDED, WAS STOPPED. PT WAS DISCHARGED 5/20/96.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention