BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD FOCALPOINT SLIDE PROFILER

    MDR report key: 3133075 · Received May 24, 2013

    Report

    Report Number
    1062336-2013-00006
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    April 26, 2013
    Manufacturer
    TRIPATH IMAGING, INC.
    Product Code
    MNM
    PMA / PMN Number
    P950009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FALSE NEGATIVE THAT RESULTED LED TO A DELAY OF DIAGNOSIS. TO DATE, BD HAS NOT CONFIRMED THE MEDICAL AND SURGICAL INTERVENTION TAKEN TO PRECLUDE SERIOUS INJURY. INTERNAL REVIEW OF THE DEVICE FALSE NEGATIVE RATE SHOWED THAT THE DEVICE PERFORMED WITHIN LABELING CLAIM AS INTENDED. NO FIELD SAFETY CORRECTIVE ACTIONS ARE PLANNED AS A RESULT OF THIS COMPLAINT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED TECHNICAL SUPPORT VIA EMAIL STATING THAT "I HAVE A HIGH GRADE MISS FROM FP037 IN 2011". TECHNICAL SUPPORT CONTACTED THE CUSTOMER SITE TO ASK ABOUT THE FALSE NEGATIVE HGSIL. THE CUSTOMER EXPLAINED THAT A REPEAT PAP WAS DONE THIS YEAR, WHICH RESULTED IN A HSIL. A RETROSPECTIVE REVIEW WAS PERFORMED FOR THE 2011 SAMPLE WHICH ALSO SHOWED A HSIL RESULT. THE 2011 REPORT WAS AMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232917 BD FOCALPOINT SLIDE PROFILER FOCALPOINT MNM TRIPATH IMAGING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1