BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTEGRA RPFA-TRAP

    MDR report key: 276894 · Received May 3, 2000

    Report

    Report Number
    2031760-2000-00001
    Event Type
    Malfunction
    Date Received
    May 3, 2000
    Date of Event
    April 5, 2000
    Report Date
    May 3, 2000
    Manufacturer
    ACCUMETRICS
    Product Code
    JOZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A BLOOD SAMPLE WAS DRAWN FROM A PT IN THE CARDIAC CATHETRIZATION LAB PRIOR TO ADMINISTRATION OF ANY "GP LLB/LLLA" INHIBITOR DRUG. THE SAMPLE WAS RUN ON THE ULTEGRA RPFA-TRAP, AND A RESULT OF 7 PAU WAS OBTAINED. BECAUSE THIS RESULT WAS SIGNFICANTLY LOWER THAN THE BASELINE (PRE-DRUG) REFERENCE RANGE CITED IN THE DEVICE PACKAGE INSERT (125 - 330 PAU), THE TEST WAS REPEATED. THE RESULT OF THE 2ND TEST WAS 38 PAU. BOTH TESTS WERE QUESTIONED BECAUSE THEY WERE MUCH LOWER THAN NORMALLY OBSERVED PRE-DRUG RPFA LEVELS. ANOTHER SAMPLE WAS DRAWN FROM THE PT AND RUN ON A DIFFERENT ANALYZER, AND THE RESULT WAS 151 PAU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTEGRA RPFA-TRAP PLATELET FUNCTION ASSAY JOZ ACCUMETRICS NA W03649

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN