MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD COR¿ MX; THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY

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	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported during use of bd cor mx instrument there was a false positive result for all mm2 targets on the cor vaginal panel assay.Confirmatory testing was performed on bd max instrument and indicated that only one target was positive.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
This complaint was the result of a request for information from the customer.The customer wanted to confirm the result on the mx using the vaginal panel assay.A bd field service engineer was dispatched to review run files and perform health check.The sample was repeated and the results were confirmed using the customer's bd max instrument.This complaint is an unconfirmed failure of the bd cor mx.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 was conducted and there were no abnormalities related to this failure mode during manufacturing acceptance testing.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 during use of bd cor mx instrument there was a false positive result for all mm2 targets on the cor vaginal panel assay.Confirmatory testing was performed on bd max instrument and indicated that only one target was positive.No adverse impact was reported regarding the patient or user.

• Brand Name: BD COR¿ MX
• Common Device Name: THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY
• 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: 22181467
• Report Number: 1119779-2025-00563
• Device Sequence Number: 15607664
• Product Code: LSL
• UDI-Device Identifier: 00382904439897
• UDI-Public: (01)00382904439897(11)221019
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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: 05/21/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• 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