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	05/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after testing on the bd cor px instrument, a software error occurred with the over-labeling function in the workflow.While this issue was being investigated by bd, it was found that this software issue may have led to false negative results due to an error with the identification software function in the instrument.No patient impact or adverse event was reported by the customer.
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.E4.Bd also notified the fda on 23 june 2025.Recall number z-2162-2025.Manufacturer narrative: it was reported by the customer that p39024 post puncture stability exceeded, aborted (inc) sample on bd cor (443988/crp0088).This issue has been investigated under a system change request.The r&d team investigated the issue for any samples that might have been impacted.Communication was provided with the potentially impacted samples and follow-up communication occurred to resolve any remaining repeat testing and anomalies.A capa was opened documenting the root cause to be a software issue that mis-identified converted sample tube history causing the workflow to assume that a newly converted sample had already been pre-warmed.This is a confirmed complaint of a bd product.Complaints for software were under statistical control for the month of may 2025.No trends indicated.Device history record review is not required for standalone software.Complaints received for this device and reported condition will continue to be tracked and trended.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.

• 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: 23289890
• Report Number: 1119779-2025-05123
• Device Sequence Number: 17510381
• Product Code: MAQ
• UDI-Device Identifier: 00382904439880
• UDI-Public: (01)00382904439880
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/19/2025

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: 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: 09/24/2025
• Initial Report FDA Received Date: 10/15/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2162-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown