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	09/18/2025
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 using another combination kit, the patient sample was negative for flu and positive for covid.There were no health impact or consequences reported.
Additional Manufacturer Narrative
Additional information - this mdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions h11: investigation summary- revision 21 of (b)(4) does not require a complaint that is type 2 reportable to open a child investigation.This child investigation was opened against a previous revision of (b)(4).Complaint investigation results: a complaint investigation has been initiated under complaint investigation child record (b)(4).The batch 6007809, in question was manufactured at the reynosa site.Device history record (dhr) review: the lot 6007809 was manufactured according to the work instruction (wi) version 79 and manufactured in the machine multivac 12 on 26/jun/2024, with a total of (b)(4) units.Glue-tubing lot: the lot# 4f03165 was manufactured according to the wi version 42 and manufactured in the machine mp04 and mp08 on 23/jun/2024, with a total of (b)(4) units.Review of the dhr showed that all relevant tests required during the related processes had been fulfilled and met the requirements.No deviation was identified, nor maintenance events were recorded related to complaint code.Conclusion summary of complaint investigation: as a result of the following: no non-conformance (nc) raised during production related to complaint code, no further actions are required.This complaint will not require further root cause investigation nor corrective and preventive action (capa) plan.Therefore, this issue will be monitored through the post market surveillance activities.
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 using another combination kit, the patient sample was negative for flu and positive for covid.There were no health impact or consequences reported.
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 using another combination kit, 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: 23393413
• Report Number: 1119779-2025-05161
• Device Sequence Number: 10047249
• 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