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

Catalog Number	443327
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd totalys multiprocessor the user was unable to use the barcode scanner of the device therefore manual entry of patient information was required.The user inadvertently entered the patient information incorrectly for two patients, swapping one for the other.The error was caught allowing the user to correct the error.No health impact or consequence reported.
Additional Manufacturer Narrative
H6: investigation summary: complaint reports mis association on multiprocessor (catalog number 443327) serial number (b)(6).Complaint alleges user error; the instrument was unable to read a barcode and requested the user input the barcode manually.User incorrectly input the barcode, thus causing a potential sample inversion.User started the process over with the correct barcode entry.No erroneous results were reported.Root cause attributed to user error.This complaint is not a confirmed failure of the instrument based on the service investigation.Review of device history record is not required because this complaint does not allege an early life failure or failure at installation and has changed configuration since release from manufacturing due to service repairs/pms.Service history review was performed, and no additional work orders were observed for the complaint failure mode reported.Review of risk management files confirms 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 "misassociation.".

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18912681
• Report Number: 1119779-2024-00208
• Device Sequence Number: 7026774
• Product Code: MKQ
• UDI-Device Identifier: 00382904433277
• UDI-Public: (01)00382904433277
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2024

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: 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: 02/23/2024
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2014
• 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