BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHAFAX APTT REAGENT

    MDR report key: 223904 · Received May 18, 1999

    Report

    Report Number
    2431530-1999-00001
    Event Type
    Malfunction
    Date Received
    May 18, 1999
    Date of Event
    April 1, 1999
    Report Date
    May 18, 1999
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS INC. HEMOLIANCE DIV
    Product Code
    GFO
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT SAMPLE THAT HAD AN APTT RESULTS OF 26 SECONDS WITH SYNTHAFAX REAGENT (LOT NO. SFX107) WAS ALSO SENT TO TWO OTHER LABS USING THIS LOT OF REAGENT. RESULTS WERE 28.9 AND 28.6. PT WAS NOT RESPONDING TO HEPARIN THERAPY AND WAS GIVEN A 2ND BOLUS OF HEPARIN. THE LAB CANNOT CONFIRM THAT THIS PT HAD COMPLICATIONS DUE TO THE ADDITIONAL HEPARIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHAFAX APTT REAGENT ACTIVATED PARTIAL THROMBOPLASTIN TIME GFO ORTHO CLINICAL DIAGNOSTICS INC. HEMOLIANCE DIV NA SFX107

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN