MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD COR PX INSTRUMENT; NUCLEIC ACID SAMPLE PREPARATION INSTRUMENT IVD

Catalog Number	443988
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: this complaint alleges that there was an issue with "aio not properly displaying px status and not functioning correctly".A field service engineer (fse) was sent on site to investigate the issue.The fse performed a power cycle, but the issue persisted and global service was contacted to further investigate the issue.Log file reviews showed that the instrument lost chain of custody when transferring a rack from a front mailbox location.Software r&d confirmed that this was a software bug, and a feedback item was created for this issue.The complaint is confirmed to be a software issue, the root cause cannot be determined based on the information provided by service.No parts were replaced as part of this complaint, and therefore no samples were available for returned material investigation.Dhr review is not required for this complaint as this complaint does not allege an early life failure or failure at installation and the configuration has changed since release from manufacturing due to service repairs/pms.Service history revealed no previous complaints for this issue.Bd quality will continue to monitor for trends associated with the failure mode described in this complaint.Review of risk management files confirms there are no new or modified risks associated with this failure mode.
Event or Problem Description
It was reported while using bd cor px, there was a loss of chain of custody with the sample rack.No adverse impact or mis-association of samples were reported regarding the patient or user.
Event or Problem Description
It was reported while using bd cor px, there was a loss of chain of custody with the sample rack.No adverse impact or mis-association of samples were reported regarding the patient or user.
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.

• Brand Name: BD COR PX INSTRUMENT
• Common Device Name: NUCLEIC ACID SAMPLE PREPARATION INSTRUMENT IVD
• 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: 24115327
• Report Number: 1119779-2026-00016
• Device Sequence Number: 18566133
• Product Code: MAQ
• UDI-Device Identifier: 00382904439880
• UDI-Public: (01)00382904439880
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P160037
• 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): 03/20/2026

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: 443988
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2024
• 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