BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTEGRA RPFA-TRAP

    MDR report key: 276879 · Received May 3, 2000

    Report

    Report Number
    2031760-2000-00002
    Event Type
    Malfunction
    Date Received
    May 3, 2000
    Date of Event
    April 10, 2000
    Report Date
    May 3, 2000
    Manufacturer
    ACCUMETRICS
    Product Code
    JOZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 ANY "GP LLB/LLLA" INHIBITOR DRUG. A TEST RESULT OF 42 PAU WAS OBTAINED. BECAUSE THIS RESULT WAS LOWER THAN THE BASELINE (PRE-DRUG) REFERENCE RANGE CITED IN THE DEVICE PACKAGE INSERT (125 - 330 PAU), THE TEST WAS REPEATED. THERE WAS A FILL ERROR, AND NO TEST RESULT WAS REPORTED. LATER, THIS BLOOD SAMPLE WAS RETRIEVED AND RUN, YIELDING A RESULT OF 0 PAU. AFTER THE PT RECEIVED A "GP LLB/LLLA INHIBITOR DRUG, THE TEST WAS RUN AGAIN AND THE RESULT WAS 16 PAU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTEGRA RPFA-TRAP PLATELET FUNCTION ASSAY JOZ ACCUMETRICS NA W03649A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN