BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTEGRA RPFA-TRAP

    MDR report key: 280682 · Received June 2, 2000

    Report

    Report Number
    2031760-2000-00005
    Event Type
    Malfunction
    Date Received
    June 2, 2000
    Date of Event
    May 3, 2000
    Report Date
    June 2, 2000
    Manufacturer
    ACCUMETRICS
    Product Code
    JOZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MANUFACTURER'S FIELD REPRESENTATIVE WAS DEMONSTRATING THE ULTEGRA RPFA-TRAP TO A DOCTOR USING A BLOOD SAMPLE OBTAINED FROM A PT WHO HAD NOT REC'D ANY "GP LLB/LLLA" INHIBITOR DRUG. A TEST RESULT OF 43 "PAU" WAS OBTAINED, WHICH IS LOWER THAN THE BASELINE (PRE-DRUG) REFERENCE RANGE CITED IN THE DEVICE PACKAGE INSERT (125-330 "PAU"). A SECOND BLOOD SAMPLE WAS DRAWN FROM THE PT, AND A TEST RESULT OF 259 "PAU" WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTEGRA RPFA-TRAP PLATELET FUNCTION ASSAY JOZ ACCUMETRICS NA W03863

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR PATIENT WAS TREATED WITH ASPIRIN, HEPARIN AND A| LIPID LOWERING DRUG.