MAUDE Adverse Event Report: TRIPATH IMAGING, INC BD FOCALPOINT¿ SLIDE PROFILER; READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Model Number	491085
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.".
Additional Manufacturer Narrative
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.
Event or Problem Description
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.".

• Brand Name: BD FOCALPOINT¿ SLIDE PROFILER
• Common Device Name: READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
• Manufacturer (Section D): TRIPATH IMAGING, INC; 1022 corporate park drive; mebane NC 27302
• Manufacturer (Section G): TRIPATH IMAGING, INC; 1022 corporate park drive; mebane NC 27302
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14323546
• Report Number: 3008007472-2022-00005
• Device Sequence Number: 4961284
• Product Code: MNM
• UDI-Device Identifier: 00382904910853
• UDI-Public: 00382904910853
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P950009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 491085
• Device Catalogue Number: 491085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown