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	07/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd veritor¿ plus analyzer, one (1) patient sample resulted as negative for group a strep.The user questioned the negative result as the patient was symptomatic and a line was visually observed on the test cartridge.Immediately after visually reading the test cartridge, it was inserted into a second veritor analyzer and a positive result for group a strep was obtained.There were no health impact or consequences reported.
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 when using the bd veritor¿ plus analyzer, one (1) patient sample resulted as negative for group a strep.The user questioned the negative result as the patient was symptomatic and a line was visually observed on the test cartridge.Immediately after visually reading the test cartridge, it was inserted into a second veritor analyzer and a positive result for group a strep was obtained.There were no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: the complaint alleges the bd veritor plus analyzer is providing discrepant results while comparing between two analyzers (catalog number 256066, serial number (b)(6).The customer received an initial negative result for group a strep; however, the patient was symptomatic.This negative result was questioned, and the same test cartridge was visually read and inserted into a second analyzer where a positive group a strep result was obtained.No verification cartridge testing was used to determine analyzer performance; however, it was noted qc passed.A replacement analyzer was provided to the customer.Quality did not receive samples for this complaint and therefore returned sample analysis could not occur.If samples are received at a later date, the complaint may be reopened.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.

• 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: 22680259
• Report Number: 1119779-2025-02178
• Device Sequence Number: 9447472
• Product Code: JJQ
• UDI-Device Identifier: 00382902560661
• UDI-Public: (01)00382902560661
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 09/22/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2023
• 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