MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD VERITOR¿ PLUS ANALYZER; DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS

Catalog Number	256066
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
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 after using the bd veritor¿ plus analyzer, the user questioned one (1) positive flu a patient result after removing and visually reading the test cartridge.The same test cartridge was reinserted into a second analyzer and a negative flu a result was obtained.There were no health impact or consequences reported.
Additional Manufacturer Narrative
The following fields have been updated with additional information: d9.Device available for eval- yes.D9.Returned to manufacturer on: 11-jul-2025.H3.Device eval by manufacturer- yes.Investigation summary - the complaint alleges the bd veritor plus analyzer is having discrepant results for flu a.(catalog number 256066, serial number (b)(6)).The customer reported that they obtained positive flu a in this affected analyzer and when they had tested on different analyzer, it is showing as negative for flu a.Bd veritor plus analyzer was returned for investigation.Troubleshooting performed for the returned analyzer and found there was a signal on the test strip which is why the results being read as positive for flu a.Therefore, this complaint is unconfirmed.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.
Event or Problem Description
It was reported after using the bd veritor¿ plus analyzer, the user questioned one (1) positive flu a patient result after removing and visually reading the test cartridge.The same test cartridge was reinserted into a second analyzer and a negative flu a result was obtained.There were no health impact or consequences reported.
Event or Problem Description
It was reported after using the bd veritor¿ plus analyzer, the user questioned one (1) positive flu a patient result after removing and visually reading the test cartridge.The same test cartridge was reinserted into a second analyzer and a negative flu a result was obtained.There were no health impact or consequences reported.
Additional Manufacturer Narrative
The following fields have been corrected: d2.Medical device type: psz.Common device name: devices detecting influenza a, b, and c virus antigens.G5.Pma / 510(k)#: k232434.

• Brand Name: BD VERITOR¿ PLUS ANALYZER
• Common Device Name: DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS
• 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: 21552387
• Report Number: 1119779-2025-00176
• Device Sequence Number: 12806916
• Product Code: PSZ
• UDI-Device Identifier: 00382902560661
• UDI-Public: (01)00382902560661(11)221107
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K232434
• 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): 09/11/2025

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: 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: 02/08/2025
• Supplement Date Received by Manufacturer: 07/16/2025; 09/08/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 07/22/2025; 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2022
• 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