MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD COR¿ MX; DNA-REAGENTS, NEISSERIA

Catalog Number	443989
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported after using bd cor mx instrument, there was 1 false positive result for the trichomonas vaginalis panel.Confirmatory testing was performed on the bd max, where the result was negative.After observing the bd cor graphs, the customer discovered that the sample had just crossed the threshold to be called positive.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
D2a.Dna probe, nucleic acid amplification, chlamydia, trichomonas vaginalis nucleic acid amplification test system, nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections.D2b.Mkz, ouy, qep.D.4.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: this complaint alleges the bd cor mx had a sample that received a false positive result for tv and unresolved for ct/gc.It is the customer's protocol to repeat unresolved results on the bd max, where a negative was received for all tests on this specimen.No instrument issues were detected; the unit is functioning correctly.A case has been created to investigate the reagents used during this testing.This complaint is an unconfirmed instrument failure.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.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 for manufacturing due to service repairs/pms.Service history review revealed there was one previous complaint 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 after using bd cor mx instrument, there was 1 false positive result for the trichomonas vaginalis panel.Confirmatory testing was performed on the bd max, where the result was negative.After observing the bd cor graphs, the customer discovered that the sample had just crossed the threshold to be called positive.No adverse impact was reported regarding the patient or user.

• Brand Name: BD COR¿ MX
• Common Device Name: DNA-REAGENTS, NEISSERIA
• 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: 21691589
• Report Number: 1119779-2025-00215
• Device Sequence Number: 21026241
• Product Code: LSL
• UDI-Device Identifier: 00382904439897
• UDI-Public: (01)00382904439897(11)220125
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K210585
• 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): 06/05/2025

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: 443989
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2022
• 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