BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B-D DIRECTIGEN EZ KIT FOR RSV RAPID ANTIGEN

    MDR report key: 1381551 · Received May 5, 2009

    Report

    Report Number
    1381551
    Event Type
    Malfunction
    Date Received
    May 5, 2009
    Date of Event
    April 11, 2009
    Report Date
    May 4, 2009
    Manufacturer
    BECTON DICKINSON
    Product Code
    GQG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY SYNCYTIAL VIRUS (RSV) RAPID ANTIGEN ASSAYS WERE ORDERED ON PATIENTS ON TWO CONSECUTIVE DAYS. AFTER THIRTEEN RESULTS WERE REPORTED POSITIVE USING THE BECTON DICKINSON DIRECTIGEN EZ KITS, THE DIRECTOR WAS NOTIFIED AS WELL AS THE MEDICAL DIRECTOR OF HOSPITAL EPIDEMIOLOGY & INFECTION CONTROL. RSV ANTIGEN ASSAYS WERE FOLLOWED UP WITH PCR AND CULTURE FOR CONFIRMATION. BD TECHNICAL SERVICES WERE NOTIFIED AND A CONFERENCE CALL FOLLOWED THREE DAYS AFTER THE REPORTED POSITIVE RESULTS. WE HAD A TOTAL OF SEVENTEEN POSITIVES AND ALL SEVENTEEN WERE FALSE POSITIVES. BD SCIENTIFIC GROUP CAME TO OUR LAB TEN DAYS LATER FOLLOWING THE CONFERENCE CALL TO RUN THE SAMPLES TO SEE IF THEY COULD DETERMINE THE PROBLEM. LOT NUMBERS INCLUDED 8296111, 8330466 AND 829126. AWAITING BD'S EVALUATION OF THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B-D DIRECTIGEN EZ KIT FOR RSV RAPID ANTIGEN LAB REAGENT KIT GQG BECTON DICKINSON * 8296111, 8330466, 8296126

    Patients

    Seq Age Sex Outcome Treatment
    1 *