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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Report 3 of 4.It was reported while using the bd veritor¿ plus analyzer, a negative sars covid result for one (1) patient sample was obtained.However, the user visually observed lines on the test cartridge and questioned the negative result interpreting the lines as a positive result.It should be noted the action of visual interpretation of a test cartridge is considered off-label use of the product.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)#: eua201889.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: the complaint alleges the bd veritor plus analyzer had a discrepant results issue (catalog number 256066, serial number (b)(6)).The customer reported that veritor covid test cartridges showed positive lines visually, but the analyzer displayed negative results.The issue occurred only with covid test kits; other test kits functioned normally.Initially, a verification cartridge was planned to be sent, but this was not done after confirming that other tests were working properly.It was determined that the customer had been incubating the covid test cartridges for only 10 minutes.The customer was informed that, per the instructions for use (ifu), incubation must be 15 minutes and no longer than 20 minutes before inserting the cartridge into the analyzer.The customer agreed to follow the correct incubation instructions and monitor whether the issue reoccurs.This is not true instrument failure, thus the complaint is not 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.
Event or Problem Description
Report 3 of 4.It was reported while using the bd veritor¿ plus analyzer, a negative sars covid result for one (1) patient sample was obtained.However, the user visually observed lines on the test cartridge and questioned the negative result interpreting the lines as a positive result.It should be noted the action of visual interpretation of a test cartridge is considered off-label use of the product.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: 24294713
• Report Number: 1119779-2026-00120
• Device Sequence Number: 9332622
• Product Code: JJQ
• UDI-Device Identifier: 00382902560661
• UDI-Public: (01)00382902560661
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 03/27/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• 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