BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD FOCALPOINT¿ SLIDE PROFILER

    MDR report key: 5752626 · Received June 27, 2016

    Report

    Report Number
    3004173866-2016-00001
    Event Type
    Injury
    Date Received
    June 27, 2016
    Date of Event
    July 9, 2015
    Report Date
    June 27, 2016
    Manufacturer
    TRIPATH IMAGING, INC
    Product Code
    MNM
    PMA / PMN Number
    P950009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BD FOCALPOINT¿ SLIDE PROFILER IS AN AUTOMATED CERVICAL CYTOLOGY SCREENING DEVICE INTENDED FOR USE IN INITIAL SCREENING OF CERVICAL CYTOLOGY SLIDES. THE PAP TEST IS A SCREENING TEST FOR CERVICAL CYTOLOGY SPECIMENS. ACCORDING TO THE BETHESDA SYSTEM FOR REPORTING CYTOLOGY, WHILE ENDOCERVICAL ADENOCARCINOMAS MAY BE DIRECTLY SAMPLED, THE DETECTION OF ENDOMETRIAL ADENOCARCINOMA DEPENDS ON EXFOLIATED CELLS BEING PRESENT IN THE COLLECTED SPECIMEN. QC REVIEW OF THE 2015 SUREPATH SLIDE SHOWS THE PRESENCE OF 10 TO 12 ATYPICAL ENDOMETRIAL GROUPS (CANNOT EXCLUDE ADENOCARCINOMA). BD QUALITY HAS REVIEWED THE COMPLAINT OF ONE FALSE NEGATIVE, CASE OF ENDOMETRIAL ADENOCARCINOMA THAT WAS CALLED ¿NO FURTHER REVIEW¿ (NFR) ON THE FOCAL POINT. THE DATA PROVIDED BY THE CUSTOMER WAS REVIEWED BY BD. BASED ON THE NUMBER OF SLIDES CLASSIFIED AS NFR IN JULY 2015 (N= (B)(4)), IT WAS AGREED THAT THE FALSE NEGATIVE RESULT OBTAINED IS WITHIN THE INSTRUMENT CLINICAL PERFORMANCE CLAIMS. REVIEW OF THE DATA ALSO REVEALED NO INDICATION OF AN INSTRUMENT MECHANICAL ISSUE DURING THE TIME FRAME WHERE THE FALSE NEGATIVE RESULT WAS OBTAINED. NO TREND IS IDENTIFIED FOR FALSE NEGATIVE COMPLAINTS AT THIS TIME. BD WILL CONTINUE TO MONITOR. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PATIENT SLIDE WAS PROCESSED BY THE FOCALPOINT AS NO FURTHER REVIEW (NFR) ON (B)(6) 2015. THE CASE WAS REPORTED TO PHYSICIAN AS NFR. NFR RESULTS ARE TREATED AS A NEGATIVE RESULT. PATIENT UNDERWENT A ENDOMETRIAL BIOPSY ON (B)(6) 2016 AND THE CYTOLOGY PAP TEST WAS REPEATED ON (B)(6) 2016. THE PATHOLOGIST DIAGNOSIS FOR CYTOLOGY AND HISTOLOGY WAS ENDOMETRIAL ADENOCARCINOMA. THE MALIGNANT DIAGNOSIS TRIGGERED A REVIEW OF THE PREVIOUS NEGATIVE SLIDE. THE SLIDE WAS PULLED AND REVIEWED MANUALLY BY TWO SENIOR CYTOTECHNOLOGISTS AND CLASSIFIED AS ENDOMETRIAL ADENOCARCINOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405972 BD FOCALPOINT¿ SLIDE PROFILER FOCAL POINT SLIDE PROFILER MNM TRIPATH IMAGING, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening