BEUDAMED
    FDA Adverse Event Other Summary report: N

    BV BLUE, GRYPHUS DIAGNOSTICS

    MDR report key: 1052145 · Received May 23, 2008

    Report

    Report Number
    MW5007024
    Event Type
    Other
    Date Received
    May 23, 2008
    Date of Event
    April 27, 2008
    Report Date
    May 23, 2008
    Product Code
    MXB
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BACTERIAL VAGINOSIS TEST KIT FAILURE RESULTING IN FALSE POSITIVE RESULTS. IN 2008, BV RESULTS REVIEWED, NOTED SIGNIFICANT INCREASE IN POSITIVE TESTS STARTING APPROXIMATELY ABOUT 2 WEEKS BEFORE. MICRO QUALITY CONTROL RECORDS INDICATED THAT A NEW LOT NUMBER #B2042- BV KIT HAD BEEN OPENED ABOUT 3 DAYS PRIOR. ISSUE REPORTED TO MFR AND KITS RETURNED. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: BACTERIAL VAGINOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV BLUE, GRYPHUS DIAGNOSTICS NONE MXB B2042

    Patients

    Seq Age Sex Outcome Treatment
    1 Other