BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTEGRA RPFA-TRAP

    MDR report key: 300774 · Received October 12, 2000

    Report

    Report Number
    2031760-2000-00011
    Event Type
    Malfunction
    Date Received
    October 12, 2000
    Date of Event
    September 12, 2000
    Report Date
    October 12, 2000
    Manufacturer
    ACCUMETRICS
    Product Code
    JOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AS PART OF A CLINICAL TRIAL INVOLVING PLATELET FUNCTION MEASUREMENTS WITH THE ULTEGRA RPFA, A BLOOD SAMPLE WAS DRAWN FROM A STUDY SUBJECT. PRIOR TO ADMINISTRATION OF ANY PLATELET INHIBITOR DRUGS, AN RPFA-TRAP RESULT OF 6 PAU WAS OBTAINED. THIS VALUE IS SUSPECT BECAUSE IT IS SIGNIFICANTLY LOWER THAN THE BASELINE REFERENCE RANGE CITED IN THE DEVICE PACKAGE INSERT (125-330 PAU). THE TEST WAS REPEATED, AND THE RESULT WAS 308 PAU. THE ANALYZER AND CARTRIDGES WERE LABELED "INVESTIGATIONAL USE ONLY", AND NO DECISIONS REGARDING PT CARE WERE MADE BASED ON THESE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTEGRA RPFA-TRAP PLATELET FUNCTION ASSAY JOZ ACCUMETRICS NA W11584

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR