MAUDE Adverse Event Report: TRIPATH IMAGING, INC BD SUREPATH MANUAL METHOD KIT; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Catalog Number	491266
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while testing with bd surepath manual method kit a slide was manually made that did not contain pathological cells consistent with the previous clinical findings.Another slide was made using the same vial but with another method and the slide contained the pathological cells.No patient impact reported.
Additional Manufacturer Narrative
Investigation summary: the customer complaint was for conflicting results possibly due to problems with coating on glass slides.The customer communicated that the error occurred from kit 491266, kit bd surepath manual method, lot number 3278371.A review of the bill of materials (bom) found that subcomponent 700013131 lot 3199139 were the slides used in 491266 lot 3278371 and related to the defect observed.A 12-month complaint review for the defect mode was performed that indicates previous complaints for coating issues for the item number but not for the lot number.Bd performs regular trending to determine if a corrective and preventative action (capa) is required, and as of this time the threshold for a capa has not been reached.Bd will continue to monitor and evaluate trends.A review of the manufacturing dhr for the lot number identified that it was complete and accurate with no indication of abnormal activities during manufacturing.Quality inspection of the slides passed for all inspection criteria.A sample was not returned but pictures were provided of prepared slides and various consumables that were used during testing.The pictures provided show cellular material on the prepared slides.If a coating issue were to occur, then cellular material would not be present on the slides.Ten (10) slides from a bd retain tray for the lot number were tested for coating defects.The coating defect test is a destructive test where the slides are dipped into a dye that binds to the precoat reagent, turning it a light pink color which provides a visual indicator of coating defects.A slide resulting in an even pink stain correlates to the slide being coated properly with the precoat solution, and a slide without even pink staining (i.E., clear) correlates to the slide being coated improperly (i.E cells would not adhere to the slide because the precoat solution is not present).All slides passed testing criteria and did not exhibit coating defects.Therefore, the complaint is not confirmed.
Event or Problem Description
It was reported while testing with bd surepath manual method kit a slide was manually made that did not contain pathological cells consistent with the previous clinical findings.Another slide was made using the same vial but with another method and the slide contained the pathological cells.No patient impact reported.

• Brand Name: BD SUREPATH MANUAL METHOD KIT
• Common Device Name: PROCESSOR, 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19005993
• Report Number: 3008007472-2024-00006
• Device Sequence Number: 9438174
• Product Code: MKQ
• UDI-Device Identifier: 00382904912666
• UDI-Public: (01)00382904912666
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: P970018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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 Expiration Date: 07/17/2025
• Device Catalogue Number: 491266
• Device Lot Number: 3278371
• 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: 03/04/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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