BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPCOR

    MDR report key: 286009 · Received June 29, 2000

    Report

    Report Number
    286009
    Event Type
    Malfunction
    Date Received
    June 29, 2000
    Date of Event
    June 20, 2000
    Report Date
    June 27, 2000
    Manufacturer
    AMPCOR TECHNOLOGIES INC. (ATI
    Product Code
    MYR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SINCE USING THE AMPCOR RPR KIT IN APRIL-MAY 2000 A 30% DECREASE (3.5% TO 2.2%) IN RPR POSITIVITY RATE HAS BEEN OBSERVED. THE LAB HAS RECEIVED COMPLAINTS OF TITERS BEING TOO LOW. THE PARALLEL TEST OF AMPCOR ANTIGEN VS. ASI AND BD ANTIGEN FAILED IN ONE OF THREE LABORATORIES. A 20% DROP (9.25% TO 7.4%) IN CONFIRMED POSITIVES (POSITIVE FTA'S/TOTAL SPECIMENS TESTED) HAS ALSO BEEN OBSERVED FOR THAT TIME PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPCOR RPR TEST KIT MYR AMPCOR TECHNOLOGIES INC. (ATI * 1138

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other