BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTEGRA RPFA-TRAP

    MDR report key: 302738 · Received October 26, 2000

    Report

    Report Number
    2031760-2000-00012
    Event Type
    Malfunction
    Date Received
    October 26, 2000
    Date of Event
    September 28, 2000
    Report Date
    October 26, 2000
    Manufacturer
    ACCUMETRICS
    Product Code
    JOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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 56 PAU WAS OBTAINED. THIS VALUE IS SIGNIFICANTLY LOWER THAN THE BASELINE REFERENCE RANGE CITED IN THE DEVICE PACKAGE INSERT (125-330 PAU). TEN MINUTES AFTER ADMINISTRATION OF EPTIFIBATIDE ANOTHER BLOOD SAMPLE WAS DRAWN, AND A POST BOLUS TEST RESULT OF 17 PAU WAS OBTAINED. A SECOND ADMINISTRATION (BOLUS) OF EPTIFIBATIDE WAS GIVEN. ANOTHER BLOOD SAMPLE WAS DRAWN TEN MINUTES AFTER THE SECOND BOLUS, AND A RESULT OF 18 PAU WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTEGRA RPFA-TRAP PLATELET FUNCTION ASSAY JOZ ACCUMETRICS NA W12201

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN THE BASELINE SAMPLE WAS DRAWN.| EPTIFIBATIDE (INTEGRILIN) WAS ADMININSTERED AFTER