BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTEGRA RPFA-TRAP

    MDR report key: 283546 · Received June 22, 2000

    Report

    Report Number
    2031760-2000-00006
    Event Type
    Malfunction
    Date Received
    June 22, 2000
    Date of Event
    May 23, 2000
    Report Date
    June 22, 2000
    Manufacturer
    ACCUMETRICS
    Product Code
    JOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MANUFACTURER'S FIELD REP WAS DEMONSTRATING THE ULTEGRA RPFA-TRAP TO A DR USING A BLOOD SAMPLE OBTAINED FROM A PT WHO HAD NOT RECEIVED A GP LLB/LLLA INHIBITOR DRUG. A TEST RESULT OF A "PAU" WAS OBTAINED. A SECOND BLOOD SAMPLE WAS DRAWN FROM THE ARTERIAL SHEATH, AND THE TEST RESULT WAS 14 PAU. THESE RESULTS ARE LOWER THAT THE BASELINE (PRE-DRUG) REFERENCE RANGE CITED IN THE DEVICE PACKAGE INSERT (125 - 330 PAU). THE PHYSICIAN DECIDED NOT TO ADMINISTER GP LLB/LLLA INHIBITOR DRUG IN CONJUNCTION WITH THE ANGIOPLASTY PROCEDURE. AFTER THE PROCEDURE, A THIRD BLOOD SAMPLE WAS TAKEN, AND A TEST RESULT OF 210 PAU WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTEGRA RPFA-TRAP PLATELET FUNCTION ASSAY JOZ ACCUMETRICS NA W03876, W03893A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR PT RECEIVED HEPARIN AND ASPIRIN PRIOR TO BLOOD| DRAWS.