BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTEGRA RPFA-TRAP

    MDR report key: 285319 · Received July 7, 2000

    Report

    Report Number
    2031760-2000-00007
    Event Type
    Malfunction
    Date Received
    July 7, 2000
    Date of Event
    June 8, 2000
    Report Date
    July 7, 2000
    Manufacturer
    ACCUMETRICS
    Product Code
    JOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 239 PAU WAS OBTAINED. NO CP IIB/IIIA INHIBITOR DRUGS WERE ADMINISTERED TO THE PT. FIFTEEN MINUTES AFTER THE FIRST TEST, A SECOND BLOOD SAMPLE WAS OBTAINED AND TESTED. THE ANALYZER REPORTED A RESULT OF 45 PAU, WHICH IS SIGNIFICANTLY LOWER THAN THE BASELINE REFERENCE RANGE CITED IN THE DEVICE PACKAGE INSERT (125-330 PAU).

    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 81 YR PLAVIX, OR ANY GP IIB/IIIA INHIBITOR.| THE PT DID NOT RECEIVE ASPIRIN, COUMADIN, HEPARIN,