MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD FOCALPOINT¿ SLIDE PROFILER; READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Catalog Number	491464
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd focalpoint¿ slide profiler classified a slide as negative requiring no further review.The slide was reviewed by the laboratory and determined to be positive.There was no report of patient impact.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: this complaint alleges false negative result on the focalpoint instrument (catalog number: 491464) serial number: (b)(6).The customer reported a circumstance were a slide reported negative, lab process compatibility assessment (lpca) has been run with the current staining too dark.Service advised the customer there were issues with the staining due to not performing the lpca after their adjustments.Root cause not determined, and this complaint is not a confirmed failure of the instrument.Samples were not received by quality for investigation and thus, returned material investigation could not occur.Device history record review revealed no abnormalities during build and test of this unit prior to shipping, as it is related to the failure mode reported.Service history review was performed for the instrument and no additional work orders were observed for the complaint failure mode reported.Review of risk management files confirm there are no new or modified risks associated with this failure mode.There are no corrective action plans or other corrections occurring.Bd quality will continue to monitor for trends associated with failure of results.
Event or Problem Description
It was reported that the bd focalpoint¿ slide profiler classified a slide as negative requiring no further review.The slide was reviewed by the laboratory and determined to be positive.There was no report of patient impact.

• Brand Name: BD FOCALPOINT¿ SLIDE PROFILER
• Common Device Name: READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19163973
• Report Number: 1119779-2024-00305
• Device Sequence Number: 15441000
• Product Code: MNM
• UDI-Device Identifier: 00382904914646
• UDI-Public: (01)00382904914646
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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 Catalogue Number: 491464
• 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: 03/25/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2018
• 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