MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) SEE H.10

Model Number 256045

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

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

Event Date 03/22/2023

Event Type  malfunction  

Manufacturer Narrative

D1: medical device brand name: bd veritor¿ system for rapid detection of flu a+b clia-waved kit d2a: common device name: antigens, cf (including cf control), influenza virus a, b, c.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 bd veritor¿ system for rapid detection of flu a+b clia-waved kit customer read test for symptomatic patient per ifu and obtained a negative result.Because there was visual distinction customer read the test on a different analyzer and got a positive result.The following information was provided by the initial reporter: customer read the test at 10 min, per ifu, and got a neg result.Because there was a visually distinctive test line, customer read the test in 4 minutes on another veritor analyzer, and got the pos result.Patient was supposedly symptomatic.

Manufacturer Narrative

Investigation summary this statement is to summarize the investigation results regarding the complaint that alleges ¿false negative result¿ when using kit flu a+b 30 test physician veritor (material # 256045), batch number 2339140.Based on the provided information, it was understood that the customer suspects the result was false negative because there was a visually distinctive test line on the cartridge.According to them, they read the test at 10 min, per ifu, and got a negative result.At the 10-minute mark when it was time to read the test, a red positive line was very clear and evident on influenza a with the naked eye, however when placed into the reader, it said negative.Customer read the same test cartridge in 4 minutes on another veritor analyzer and got the positive result.Bd quality performs a systematic approach to investigate false negative result complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.Bhr (batch history review) analysis and retain sample testing were performed on the batch number provided and no issues were found, and results were acceptable.No physical samples were returned, therefore, return sample analysis could not be performed, however customer sent a photograph of test cartridge, which shown red line in the test window.The reported issue could not be determined based on the photograph, because this test is not designed to read visually, the results must be determined using the bd veritor instrument only.Customer had read the same cartridge second time in the different machine, which is not recommended by bd.The complaint was unable to be confirmed.A trend analysis for false negative was conducted, no adverse trend was identified.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.

Event Description

It was reported that bd veritor¿ system for rapid detection of flu a+b clia-waved kit customer read test for symptomatic patient per ifu and obtained a negative result.Because there was visual distinction customer read the test on a different analyzer and got a positive result.The following information was provided by the initial reporter: customer read the test at 10 min, per ifu, and got a neg result.Because there was a visually distinctive test line, customer read the test in 4 minutes on another veritor analyzer, and got the pos result.Patient was supposedly symptomatic.

• Brand Name: SEE H.10
• Type of Device: SEE H.10
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16748914
• MDR Text Key: 313522828
• Report Number: 1119779-2023-00427
• Device Sequence Number: 1
• Product Code: GNX
• UDI-Device Identifier: 00382902560456
• UDI-Public: 00382902560456
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132692
• 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: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 256045
• Device Catalogue Number: 256045
• Device Lot Number: 2339140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• 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