BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEHRING FIBRINTIMER A

    MDR report key: 129692 · Received July 1, 1997

    Report

    Report Number
    129692
    Event Type
    Injury
    Date Received
    July 1, 1997
    Date of Event
    May 29, 1996
    Report Date
    June 20, 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 WAS HOSPITALIZED ON 5/27/96 WITH CHF AND RENAL FAILURE, WORSENING. LAB WORK 5/29/96 1204 FOR C3 AND C4 COMPLIMENT DRAWN. RESULTS BACK 5/30/96 VERY LOW. PT SCHEDULED TO BE TREATED FOR CRYOGLOBULINEMIA, STARTED IMMEDIATELY ON STEROID THERAPY AND SCHEDULED FOR PLASMA PHERESIS 1 TO 3 TIMES SOON. ON 6/3/96, A PERM CATH WAS PLACED AND PLASMA PHERESIS WAS STARTED. CORRECTED LAB VALUES FROM 5/29/96. BLOOD OBTAINED AND PROCEDURE TERMINATED. CONDITION CONTINUED TO DETERIORATE AND PT EXPIRED ON 6/4/96.

    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 79 YR Life Threatening| R