MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) INSTRUMENT BD TOTALYS MULTIPROCESSOR

Model 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	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using the instrument bd totalys multiprocessor that there was mis-association of data.The following information was provided by the initial reporter: if salesforce pir complaint, date received: customer problem: the customer reports when the cytologist looked at 4 slides they saw that they were mismatched and wanted to know why.The customer wanted it documented they had 4 mismatch slides.
Additional Manufacturer Narrative
H.6 investigation summary: complaint reports slide mismatch failure on multiprocessor (catalog number 443327) serial number tm0100.Complaint alleges cytologist looked at four slides and noticed they were mismatched.Service had customer reprocess the samples manually using the prepmate and slideprep.Cytologist compared the slides of the manually processed and slides processed with the multiprocessor and they matched.In conclusion the multiprocessor operates normally.Root cause not determined, and this complaint is not a confirmed failure of the instrument based on the service investigation.Review of device history record for instrument serial number, tm0100 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.Device was installed on 07/15/2020.Service history review was performed for the instrument tm0100, 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.".
Event or Problem Description
It was reported that while using the instrument bd totalys multiprocessor that there was mis-association of data.The following information was provided by the initial reporter: if salesforce pir complaint, date received:.Customer problem: the customer reports when the cytologist looked at 4 slides they saw that they were mismatched and wanted to know why.The customer wanted it documented they had 4 mismatch slides.

• Brand Name: INSTRUMENT BD TOTALYS MULTIPROCESSOR
• Common Device Name: NA
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16820703
• Report Number: 1119779-2023-00483
• Device Sequence Number: 20586713
• Product Code: MKQ
• UDI-Device Identifier: 00382904433277
• UDI-Public: 00382904433277
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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 Model Number: 443327
• 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: 03/30/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2019
• 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