BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOCALPOINT SLIDE PROFILER

    MDR report key: 632286 · Received August 8, 2005

    Report

    Report Number
    1062336-2004-00001
    Event Type
    Injury
    Date Received
    August 8, 2005
    Date of Event
    January 1, 2003
    Report Date
    April 5, 2004
    Manufacturer
    TRIPATH IMAGING, INC.
    Product Code
    MKQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A LABORATORY CUSTOMER REPORTED THAT A PATIENT'S CONVENTIONAL PAP SMEAR SLIDE WAS CLASSIFIED BY THE FOCAL POINT AS NO FURTHER REVIEW (NFR) IN THE SUMMER OF 2003. THE PATIENT RETURNED TO THE PHYSICIAN WITH SYMPTOMS OF POST COITAL BLEEDING. A SUREPATH PAP SPECIMEN WAS COLLECTED IN 2004 AND WAS CLASSIFIED BY THE FOCALPOINT AS REVIEW AND PLACED IN QUINTILE 1. THE LABORATORY REPORTS THAT IT'S FOLLOW UP TO REVIEW PRIOR SLIDES FOR THE PATIENT REVEALED THAT AN HSIL RESULT WAS CLASSIFIED AS NFR IN 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCALPOINT SLIDE PROFILER AUTOMATED PAP SCREENING SYSTEM MKQ TRIPATH IMAGING, INC. FOCALPOINT SLIDE PROFILER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other