BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTEGRA RPFA-TRAP

    MDR report key: 286016 · Received July 13, 2000

    Report

    Report Number
    2031760-2000-00008
    Event Type
    Malfunction
    Date Received
    July 13, 2000
    Date of Event
    June 14, 2000
    Report Date
    July 13, 2000
    Manufacturer
    ACCUMETRICS
    Product Code
    JOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A BLOOD SAMPLE WAS DRAWN FROM A PT TO OBTAIN A BASELINE (PRE-DRUG) PLATELET FUNCTION TEST RESULT USING THE ULTEGRA RPFA-TRAP. A RESULT OF 50 PAU WAS OBTAINED. THIS VALUE IS SIGNIFICANTLY LOWER THAN THE BASELINE REFERENCE RANGE CITED IN THE DEVICE PACKAGE INSERT (125-330 PAU). AFTER ADMINISTRATION OF EPTIFIBATIDE, ANOTHER BLOOD SAMPLE WAS DRAWN, AND A TEST RESULT OF 38 PAU WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTEGRA RPFA-TRAP PLATELET FUNCTION ASSAY JOZ ACCUMETRICS NA W03893A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR THE BASELINE SAMPLE.| EPTIFIBATIDE (INTEGRILIN) WAS ADMINISTERED AFTER