BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVATED THROMBOFAX TM REAGENT-OPTIMIZED

    MDR report key: 88105 · Received April 22, 1997

    Report

    Report Number
    2250051-1997-00024
    Event Type
    Malfunction
    Date Received
    April 22, 1997
    Date of Event
    March 22, 1997
    Report Date
    April 18, 1997
    Manufacturer
    ORTHO DIAGNOSTIC SYSTEMS, INC.
    Product Code
    GFO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED TO HOSPITAL DUE TO BLEEDING FROM OVERDOSE OF HEPARIN. HEPARIN THERAPY WAS ADMINISTERED BASED ON CLOTTING RESULTS. LAB REPORTED RESULTS WITH CO'S DEVICE AND ANOTHER DEVICE WITHOUT PERFORMING THE HEPARIN IN VITRO CURVE AS INDICATED IN THE DIRECTION CIRCULAR. HOSPITAL RESULTS REPORTED GREATER THAN 200 SECONDS USING AND ELECTRA TWO DEVICES. THIS REPORT CORRESPONDS TO CO COMPLAINT NUMBER 97-01812-04.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVATED THROMBOFAX TM REAGENT-OPTIMIZED APTT REAGENT GFO ORTHO DIAGNOSTIC SYSTEMS, INC. NA ACT151

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other 3/24 - PT AT HOME| 3/19-STOP COUMADIN THERAPY 3-21-START HEPARIN| 3/22-HEPARIN-18,000 USQ. Q8| 3/23 AT 1:00 BLEEDING PROTAMINE GIVE| 18,000 USQ. Q8.