BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVATED THROMBOFAX REAGENT-OPTIMI

    MDR report key: 59683 · Received October 2, 1996

    Report

    Report Number
    2250051-1996-00013
    Event Type
    Malfunction
    Date Received
    October 2, 1996
    Date of Event
    August 13, 1996
    Report Date
    September 24, 1996
    Manufacturer
    ORTHO DIAGNOSTIC SYSTEMS INC.
    Product Code
    GFO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    PT WAS ON HEPARIN THERAPY. AN INITIAL RESPONSE WAS OBSERVED WITH ACTIVATED REAGENT, OPTIMIZED, ON THE COAGULATION ANALYZER, SUBSEQUENT MONITORING OF THE PT OVER A PERIOD OF 17 DAYS INDICATES A RETURN TO NORMAL CLOTTINGTIMES. THE PHYSICIAN CHANGED THE PT THERAPY IN RESPONSE TO THE LABORATORY RESULTS. THE LABORATORY HAS VERIFIED DURING THE PERIOD IN QUESTION, ALL QC PARAMETERS WERE IN CONTROL AND OTHER HEPARIN PTS RESULTS WERE WITHIN THE EXPECTED RANGE. NO DEATH OR SERIOUS INJURY WAS REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVATED THROMBOFAX REAGENT-OPTIMI APTT REAGENT GFO ORTHO DIAGNOSTIC SYSTEMS INC. NA ACT140

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO