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	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown 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 totals slideprep there was possible mis-association of 7 patient samples.The cells on the slides for 7 specimens did not match the type of specimen collection source for those patients.The samples were retested from the original specimen container and the samples ran as expected.No adverse impact was reported regarding the patient or user.
Event or Problem Description
It was reported while using bd totalys slideprep there was possible mis-association of 7 patient samples.The cells on the slides for 7 specimens did not match the type of specimen collection source for those patients.The samples were retested from the original specimen container and the samples ran as expected.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The complaint alleges the slideprep instrument (catalog number 491346 and serial number (b)(6) had mis-matched slides.Customer reported multiple specimens were switched, and the instrument was running on barcode read.The cells on the slides for 7 specimens did not match the specimen collection source for those patients.Customer reran the slides, and they didn¿t match again.They reran specimens from the original collection container and those slides matched.No erroneous results were reported to patients.Service observed slideprep processing steps and workflow with operator; unable to pinpoint anything specific that could have caused mismatched slides.The instrument is performing as expected; the instrument was turned back over to the customer for normal use.This complaint is not a confirmed failure of the instrument, and the root cause cannot be determined by the information provided.Review of device history record for this instrument 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, 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.

• 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: 22742908
• Report Number: 1119779-2025-02698
• Device Sequence Number: 8385780
• Product Code: MKQ
• UDI-Device Identifier: 00382904913465
• UDI-Public: (01)00382904913465
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2025

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: 07/08/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2019
• 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