BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTEGRA RPFA-TRAP

    MDR report key: 288947 · Received August 4, 2000

    Report

    Report Number
    2031760-2000-00009
    Event Type
    Malfunction
    Date Received
    August 4, 2000
    Date of Event
    July 6, 2000
    Report Date
    August 4, 2000
    Manufacturer
    ACCUMETRICS
    Product Code
    JOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    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 56 "PAU" WAS OBTAINED. THIS VALUE IS SIGNIFICANTLY LOWER THAN THE BASELINE REFERENCE RANGE CITED IN THE DEVICE PACKAGE INSERT (125-330 "PAU"). A SECOND BLOOD SAMPLE WAS DRAWN, AND THE RETEST GAVE A RESULT OF 141 "PAU".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTEGRA RPFA-TRAP PLATELET FUNCTION ASSAY JOZ ACCUMETRICS NA W03876, W11247

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN