BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTEGRA RPFA-TRAP

    MDR report key: 300656 · Received October 10, 2000

    Report

    Report Number
    2031760-2000-00010
    Event Type
    Malfunction
    Date Received
    October 10, 2000
    Date of Event
    July 17, 2000
    Report Date
    October 9, 2000
    Manufacturer
    ACCUMETRICS INC.
    Product Code
    JOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    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 47 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). IT IS NOT KNOWN WHETHER THE VALUE WAS INACCURATE BECAUSE A REPEAT TEST WAS NO PERFORMED ON THE BLOOD SAMPLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN WAS TREATED WITH LOVENOX.| PT HAD NOT RECEIVED ANTI-PLATELET DRUGS.