MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD VERITOR ¿ SARS-COV-2 & FLU A+B; NOT CLASSIFIED

Catalog Number 256088

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

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

Event Date 07/18/2023

Event Type  malfunction  

Manufacturer Narrative

E.1.Initial reporter addr 1: (b)(6).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

Report 1 of 4 it was reported that while using bd veritor ¿ sars-cov-2 & flu a+b, one patient experienced discrepant results when testing for flu a.No patient impact was reported.The following information was provided by the initial reporter: "on (b)(6) 2023, 1 symptomatic patient was tested by triplex 256088, and was pod for flu a; patient was tested for 256045 lot 2316009 (verifying this lot #), and were neg bot both, flu a and b; patient reported as positive".

Manufacturer Narrative

Investigation summary: this statement is to summarize the investigation results regarding a complaint that alleges false positive results when using bd veritor¿ sars-cov-2 and flu a+b (material # 256088), batch numbers 2364051.The customer reported that 2 symptomatic patients were tested with triplex 256088, and both were positive for flu a.The same patients were tested with 256045, and the results were negative bot both flu a and b.On the next day 2 asymptomatic employees swabbed themselves and used the same product kits 256088 and 256045 to test themselves.They both came out positive for flu a with 256088, and negative for both flu a and b with 256045.The customer was suspicious about the positive results obtained from triplex and they were not alleging any issue with the flu kit 256045.The customer did not mention any alternative (pcr) tests.Bd quality performs a systematic approach to investigate false positive complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.Batch history record (bhr) review and retain sample analysis were performed on the batch number provided.Results were acceptable and no relevant issue was found.No photos or samples were received; therefore, return sample analysis could not be performed.This complaint was unable to be confirmed.The root cause could not be identified.Currently no adverse trend for false positive was identified.

Event Description

Report 1 of 4 it was reported that while using bd veritor ¿ sars-cov-2 & flu a+b, one patient experienced discrepant results when testing for flu a.No patient impact was reported.The following information was provided by the initial reporter: "on 07/18/23, 1 symptomatic patient was tested by triplex 256088, and was pod for flu a; patient was tested for 256045 lot 2316009 (verifying this lot #), and were neg bot both, flu a and b; patient reported as positive.

• Brand Name: BD VERITOR ¿ SARS-COV-2 & FLU A+B
• Type of Device: NOT CLASSIFIED
• 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: 17375005
• MDR Text Key: 319554366
• Report Number: 1119779-2023-00792
• Device Sequence Number: 1
• Product Code: QMN
• 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: 10/30/2023

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
• Device Operator: Other
• Device Expiration Date: 04/10/2024
• Device Catalogue Number: 256088
• Device Lot Number: 2364051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 10/30/2023
• Supplement Dates FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2022
• 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