BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD AFFIRM VPIII MICROBIAL IDENTIFICATION TES

    MDR report key: 1053579 · Received May 29, 2008

    Report

    Report Number
    1119779-2008-00007
    Event Type
    Other
    Date Received
    May 29, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 28, 2008
    Manufacturer
    BD DIAGNOSTIC SYSTEMS
    Product Code
    JSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFIRM VPIII MICROBIAL IDENTIFICATION TEST IS A DNA PROBE TEST INTENDED FOR USE IN THE DETECTION AND IDENTIFICATION OF CANDIDA SPECIES, GARDNERELLA VAGINALIS AND TRICHOMONAS VAGINALIS NUCLEIC ACID IN VAGINAL FLUID SPECIMENS FROM PTS WITH SYMPTOMS OF VAGINITIS/VAGINOSIS. THE REAGENT CASSETTES USED FOR THIS TEST ARE COVERED WITH FOIL THAT MUST BE PEALED OFF TO ACCESS THE REAGENTS. A CROSS-FUNCTIONAL TEAM HAS BEEN CONSTRUCTED TO EVALUATE THIS ISSUE. THEY WILL INVESTIGATE TOOLS THAT CAN BE USED TO FACILITATE THE MANUAL FOIL REMOVAL PROCESS. SEVERAL OFF THE SHELF TOOLS HAVE BEEN IDENTIFIED AND ARE BEING EVALUATED ACROSS MULTIPLE USERS. ADD'L USABILITY STUDIES WILL BE CONDUCTED FOLLOWING ANY SELECT TOOL ENHANCEMENTS. IF AN ACCEPTABLE TOOL CANNOT BE FOUND, A PROPOSAL FOR A PROJECT TO DEVELOP A SOLUTION WOULD BE INITIATED.

    Description of Event or Problem · 1

    TWO TECHNICIANS HAVE BEEN DIAGNOSED AND TREATED BY A PHYSICIAN FOR CARPAL TUNNEL SYNDROME (CTS). ONE TECH WAS PREVIOUSLY DIAGNOSED AND TREATED AND HAD A RELAPSE AFTER USING THIS KIT TO PROCESS 150 SAMPLES PER DAY. THE OTHER TECH WAS NEWLY DIAGNOSED, TREATED BY THEIR PHYSICIAN AND REMOVED FROM PERFORMING THIS TEST. THE CUSTOMER FEELS THIS IS DUE TO PEALING BACK THE FOIL COVERING TO ACCESS THE TEST REAGENTS IN THE CASSETTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD AFFIRM VPIII MICROBIAL IDENTIFICATION TES JSY BD DIAGNOSTIC SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other