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

Catalog Number	443327
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
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 multiprocessor, there was a potential misassociation of 1 patient sample number.The number on the label being assigned to a patient sample was duplicated for 2 samples, which resulted in one type of test also being added to the older sample as well.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The complaint alleges the multiprocessor instrument (catalog number 443327 and serial number (b)(6)) has sample number mismatch.Customer reported duplicate cy number for different samples assigned to a test package performed in the past.This resulted in the test being added to the old package.The client uses the patarch system but is unable to determine where the numbers are generated.Customer stated no erroneous results were reported to the patient.Service confirmed the problem is associated with the patarch system.Qr codes on the slides have been leveled and should improve scanning and scanner is functioning properly.The instrument is running without any issues or errors.This complaint is not a confirmed failure of the instrument, and the root cause can be attributed to using the patarch system.Device history record review is not required because the part that allegedly failure is not tested as part of the manufacturing process but is shipped separately and tested during installation.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 for trends associated with the failure mode described in this complaint.
Event or Problem Description
It was reported while using bd totalys multiprocessor, there was a potential misassociation of 1 patient sample number.The number on the label being assigned to a patient sample was duplicated for 2 samples, which resulted in one type of test also being added to the older sample as well.No adverse impact was reported regarding the patient or user.

• Brand Name: BD TOTALYS MULTIPROCESSOR
• 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: 23393208
• Report Number: 1119779-2025-05155
• Device Sequence Number: 18609816
• Product Code: MKQ
• UDI-Device Identifier: 00382904433277
• UDI-Public: (01)00382904433277
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 11/21/2025

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: 443327
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2024
• 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