BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FOCALPOINT¿ SLIDE PROFILER

    MDR report key: 14323546 · Received May 7, 2022

    Report

    Report Number
    3008007472-2022-00005
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 7, 2022
    Report Date
    August 29, 2022
    Manufacturer
    TRIPATH IMAGING, INC
    Product Code
    MNM
    UDI-DI
    00382904910853
    PMA / PMN Number
    P950009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THIS COMPLAINT ALLEGES A FAILURE ON THE FOCALPOINT INSTRUMENT (P/N 491085, S/N (B)(6)). THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT ON THEIR INSTRUMENT. AN HSIL (SEVERE DYSPLASIA) WAS OBSERVED ON A PREVIOUSLY NO FURTHER REVIEW. A BD REPRESENTATIVE ARRIVED ONSITE TO INVESTIGATE THE COMPLAINT AND NOTED ON THE SLIDE THAT HSIL WAS PRESENT IN THE UPPER LEFT DIRECTION OF THE FIELD OF VIEW. PER THE 840-07711-00 FOCALPOINT GS FALSE NEGATIVE TEST WORK INSTRUCTION WITH 1 FALSE NEGATIVE RESULT REPORTED, THE MACHINE IS OPERATING WITHIN CLAIMS. THIS WORK INSTRUCTION PROVIDES METHODOLOGY FOR DETERMINING WHETHER THE SYSTEM IS OPERATING WITHIN THE PRODUCT INSERT CLAIMS BASED ON CLINICAL TRIAL DATA. ONCE CALCULATED IT ASSIGNS A SCORE CALLED A K VALUE. IF THE K VALUE IS GREATER THAN OR EQUAL TO THE NUMBER OF FALSE NEGATIVE SLIDES, THE MACHINE IS PERFORMING WITHIN CLAIMS. DUE TO ONLY 1 FALSE NEGATIVE RESULT BEING REPORTED THIS MEANS THE K VALUE IS WITHIN SPECIFICATION. THIS IS AN UNCONFIRMED FAILURE OF THE INSTRUMENT. SAMPLES WERE NOT RECEIVED BY QUALITY FOR INVESTIGATION AND THUS, RETURNED MATERIAL INVESTIGATION COULD NOT OCCUR. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT SERIAL NUMBER, FP0732 IS NOT REQUIRED BECAUSE THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND HAS CHANGED CONFIGURATION SINCE RELEASE FROM MANUFACTURING DUE TO SERVICE REPAIRS/PMS. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT FP0732 AND NO ADDITIONAL WORK ORDERS WERE OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. ROOT CAUSE IS PERFORMANCE VARIATION IN OPTICAL SYSTEM OR FOV. PER 840-07711-00 WORK INSTRUCTIONS: FALSE NEGATIVE TEST ¿ FOCALPOINT GS, A FALSE NEGATIVE (FN) IS DEFINED AS ¿A PATIENT SLIDE THAT HAS BEEN EVALUATED BY FOV ONLY BY THE FOCALPOINT GS¿, OPERATING AS LABELED FOR PRIMARY SCREENING THAT IS LATER DETERMINED BY MANUAL REVIEW TO BE ASCUS+.¿ FOV (FIELD OF VIEW) ONLY SLIDES ARE ¿A CATEGORY OF PATIENT SLIDES THAT HAD ONLY FOVS REVIEWED DURING PROCESSING WITH NO FULL SLIDE REVIEW DONE.¿ AND ¿ALL FOVS WERE DEEMED NORMAL, NO ABNORMALITIES DETECTED.¿ THIS IS AN UNCONFIRMED FAILURE OF A BD PRODUCT. BD WILL CONTINUE TO CLOSELY MONITOR TRENDS ASSOCIATED WITH THIS COMPLAINT. COMPLAINT HISTORY FOR RESULTS WAS REVIEWED FOR THE MONTH OF APRIL. THE UPPER CONTROL LIMIT WAS NOT BREACHED, AND TRENDS WERE NOT IDENTIFIED ASSOCIATED WITH THIS DEFECT. NO NEW TRENDS, RISKS, OR HAZARDS WERE IDENTIFIED AS A RESULT OF THIS COMPLAINT. THE ISSUE IN THIS COMPLAINT DOES NOT REQUIRE THE INITIATION OF A CORRECTIVE AND PREVENTATIVE ACTION (CAPA). THIS COMPLAINT WILL BE INCLUDED IN THE PERIODIC TREND REVIEW. HAZARD IS CAPTURED IN NCRM-FP-APH REV 10, ID 95, SEVERITY S1, RISK INDEX GR, USER INCONVENIENCE - MAY INCREASE THE NUMBER OF SLIDES REQUIRING MANUAL SCREENING. NO NEW HAZARD IDENTIFIED, NO UPDATE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FOCALPOINT¿ SLIDE PROFILER THE CUSTOMER RECEIVED FALSE NEGATIVE RESULTS. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WAS AN HSIL (SEVERE DYSPLASIA) SAMPLE AT RANK 4, AND FOV (FIELD OF VIEW) DEVIATION WAS OBSERVED IN THE SITE NAVIGATION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FOCALPOINT¿ SLIDE PROFILER THE CUSTOMER RECEIVED FALSE NEGATIVE RESULTS. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WAS AN HSIL (SEVEREDYSPLASIA) SAMPLE AT RANK 4, AND FOV (FIELD OF VIEW) DEVIATION WAS OBSERVED IN THE SITE NAVIGATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186116 BD FOCALPOINT¿ SLIDE PROFILER READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED MNM TRIPATH IMAGING, INC 491085 00382904910853

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown