MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD VERITOR PLUS ANALYZER; ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Catalog Number 256066

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2023

Event Type  malfunction  

Event Description

It was reported that while using bd veritor plus analyzer, there is one discrepant result after customer visually reads the cartridge.No patient impact reported.The following information was provided by the initial reporter: "customer states visually reading cartridge and lines are seen, run on veritor and instrument gives neg result.".

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd veritor plus analyzer, there is one discrepant result after customer visually reads the cartridge.No patient impact reported.The following information was provided by the initial reporter: "customer states visually reading cartridge and lines are seen, run on veritor and instrument gives neg result.".

Manufacturer Narrative

H.6 investigation summary: the complaint created for bd veritor plus analyzer provide discrepant result (catalog number 256066, serial number (b)(6)).Customer states the results they observed in display screen is discrepant on what they visually seeing on the cartridge.During remotely troubleshoot, customer being told to not confirm the results by visually reading, should confirm the result by what being displayed on the screen.Remotely able to solve the issue.Hence, the complaint is unconfirmed.Dhr 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.Bd quality will continue to monitor for trends related to the veritor system.

• Brand Name: BD VERITOR PLUS ANALYZER
• Type of Device: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17547488
• MDR Text Key: 321445598
• Report Number: 1119779-2023-00891
• Device Sequence Number: 1
• Product Code: JJQ
• UDI-Device Identifier: 00382902560661
• UDI-Public: 00382902560661
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1