MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD TOTALYS SLIDEPREP; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Catalog Number	491346
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 using bd totalys slideprep, there was mis-association of one patient sample to another.The instrument was running in the incorrect mode, and the slide was made without matching it to the correct barcode.No adverse impact or results were reported regarding the patient or user.
Additional Manufacturer Narrative
The complaint alleges the slideprep instrument (catalog number 491346 and serial number (b)(6) had possible contamination.Customer reported contamination of the prepared specimen is suspected.Specimens may have been prepared from different specimens.Service confirmed issue related to setting change from ¿remote station¿ to ¿positional¿.In previous service visit, the setting was changed from ¿remote station¿ to ¿positional¿ when conducting a water run to confirm functionality of the instrument.Service changed the processing setting back to ¿remote station¿ and verified the correct specimen was transferred to the correct slide; the instrument was turned back over to the customer for normal use.Service investigation revealed a potential sample mismatch, therefore there is no contamination as original reported by the customer.This complaint is not a confirmed failure of the instrument, and the root cause attributed to fse error.Review of device history record for this instrument is not required as this complaint does not allege an early life failure or failure at install of the instrument.Service history review was performed, and no additional work orders were observed for the complaint failure mode reported.No samples were expected to be received as part of this complaint, and therefore no samples were returned, and no returned material investigation could occur.Bd quality will continue to monitor trends associated with the failure mode described in this complaint.
Event or Problem Description
It was reported while using bd totalys slideprep, there was mis-association of one patient sample to another.The instrument was running in the incorrect mode, and the slide was made without matching it to the correct barcode.No adverse impact or results were reported regarding the patient or user.

• Brand Name: BD TOTALYS SLIDEPREP
• Common Device Name: PROCESSOR, 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 23485855
• Report Number: 1119779-2025-05228
• Device Sequence Number: 10228466
• Product Code: MKQ
• UDI-Device Identifier: 00382904913465
• UDI-Public: (01)00382904913465
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/26/2025

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: 491346
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2017
• 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