MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD VERITOR¿ PLUS ANALYZER; COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE

Catalog Number	256066
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 while using the bd veritor¿ plus analyzer, one (1) false positive flu b patient result was obtained, simultaneously with a positive sars-cov-2 result.Upon confirmatory testing by a lab using quad pcr, the patient sample was negative for flu and positive for covid.There were no health impact or consequences reported.
Event or Problem Description
It was reported while using the bd veritor¿ plus analyzer, one (1) false positive flu b patient result was obtained, simultaneously with a positive sars-cov-2 result.Upon confirmatory testing by a lab using quad pcr, the patient sample was negative for flu and positive for covid.There were no health impact or consequences reported.
Additional Manufacturer Narrative
The following fields have been updated with additional information: d9.Device available for evaluation: yes d9.Returned to manufacturer on: 11-nov-2025 h3.Device eval by manufacturer?: yes investigation summary: the complaint alleges the bd veritor plus analyzer is having false positives for triplex assay (catalog number 256066, serial number (b)(6).A replacement analyzer was provided to the customer.Bd veritor plus analyzer was returned for investigation.Based on the test results in the csv file, it was showing positive result for flu b which was consistent with what was displayed on the screen.However, without access to the tiff images, we are unable to determine the root cause.Therefore, this complaint is confirmed.Device history record review for veritor plus analyzer, serial number (b)(6) was reviewed and nonconformances related to this failure mode were not revealed in manufacturing during final testing.The device was released conforming.Review of risk management files confirms there are no new or modified risks associated with this failure mode.Bd quality will continue to monitor for trends associated with the failure mode described in this complaint.
Additional Manufacturer Narrative
The requested 510k information for the involved veritor assay is as follows: g4.Pma/510(k)#: eua203152.
Event or Problem Description
It was reported while using the bd veritor¿ plus analyzer, one (1) false positive flu b patient result was obtained, simultaneously with a positive sars-cov-2 result.Upon confirmatory testing by a lab using quad pcr, the patient sample was negative for flu and positive for covid.There were no health impact or consequences reported.

• Brand Name: BD VERITOR¿ PLUS ANALYZER
• Common Device Name: COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE
• 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: 23393409
• Report Number: 1119779-2025-05160
• Device Sequence Number: 15948455
• Product Code: JJQ
• UDI-Device Identifier: 00382902560661
• UDI-Public: (01)00382902560661
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.11
• 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,Followup
• Report Date (Section B): 01/06/2026

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: 256066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 11/14/2025; 01/06/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/18/2025; 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• 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