BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOCAL POINT

    MDR report key: 672954 · Received February 9, 2006

    Report

    Report Number
    1062336-2006-00001
    Event Type
    Other
    Date Received
    February 9, 2006
    Date of Event
    December 23, 2005
    Report Date
    January 9, 2006
    Manufacturer
    TRIPATH IMAGING, INC.
    Product Code
    NQN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CERVICAL CYTOLOGY PATIENT SAMPLE WAS EVALUATED BY FOCAL POINT PLATFORM IN 2003. MACHINE INDICATED THAT THE SLIDE /SMEAR NEEDED NO FURTHER REVIEW. THE SLIDE WAS RE-EVALUATED, DURING A 5 YEAR RETROSPECTIVE REVIEW OF SLIDES FOR THIS PATIENT THAT WAS PROMPTED, BECAUSE A MORE RECENT SLIDE FROM 2005 INDICATED ABNORMAL CELLS. THE REVIEW OF THE EARLIER SLIDE BY THE PATIENT'S PHYSICIAN INDICATED ABNORMAL CELLS (HSIL) NOTIFICATION OF THIS REPORT WAS RECEIVED ON JANUARY 9,2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCAL POINT AUTOMATED CERVICAL CYTOLOGY SCREENER NQN TRIPATH IMAGING, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other