MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD VERITOR ¿ AT-HOME COVID-19 TEST; NOT CLASSIFIED

Catalog Number 256094

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

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

Event Date 08/16/2023

Event Type  malfunction  

Event Description

It was reported that during use with bd veritor ¿ at-home covid-19 test multiple false positive results were obtained.Confirmatory pcr testing was performed and results were negative.There was no report of patient impact.The following information was provided by the initial reporter: customer¿s facility used bd test to test for covid, and 36 were positives and 7 negatives.Customer stopped testing the patients.Tested them again with other tests, antigen first.They were negative, and pcr¿s.They were negative.

Manufacturer Narrative

Eua # (b)(4).D.4.Medical device expiration date: unknown.E.1.Initial reporter state: address information was not able to be obtained, therefore, md was used as a place holder.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Manufacturer Narrative

H.6 investigation summary: this summarizes the investigation results regarding a complaint that alleges ¿false positive results¿ using the bd veritor at home covid-19 test (material # 256094), batch number unknown.According to the report, the customer¿s facility initially used bd veritor test for covid, which yielded 36 positive and 7 negative results.The customer decided to stop testing the patients using this method.Subsequently the patients were tested again using antigen test, which returned negative results, and then with pcr test, which also showed negative results.Bd quality performs a systematic approach to investigate all complaints.This approach involves review of manufacturing batch history records, review of software updates, testing of retention samples, and testing of customer returned samples, if applicable.Batch history record (bhr) review and retain sample testing could not be performed because a batch number was not provided.A review of bug fixes and software updates was conducted, and no issues related to this complaint were identified.This complaint cannot be confirmed.The root cause could not be identified.A trend analysis for false positive was conducted, no adverse trend was identified.

Event Description

It was reported that during use with bd veritor ¿ at-home covid-19 test multiple false positive results were obtained.Confirmatory pcr testing was performed and results were negative.There was no report of patient impact.The following information was provided by the initial reporter: customer¿s facility used bd test to test for covid, and 36 were positives and 7 negatives.Customer stopped testing the patients.Tested them again with other tests, antigen first.They were negative, and pcr¿s.They were negative.

Event Description

It was reported that during use with bd veritor ¿ at-home covid-19 test multiple false positive results were obtained.Confirmatory pcr testing was performed and results were negative.There was no report of patient impact.The following information was provided by the initial reporter: customer¿s facility used bd test to test for covid, and 36 were positives and 7 negatives.Customer stopped testing the patients.Tested them again with other tests, antigen first.They were negative, and pcr¿s.They were negative.

Manufacturer Narrative

H6.Investigation summary: this summarizes the investigation results regarding a complaint that alleges ¿false positive results¿ using the bd veritor at home covid-19 test (material # 256094), batch number unknown.According to the report, the customer¿s facility initially used bd veritor test for covid, which yielded 36 positive and 7 negative results.The customer decided to stop testing the patients using this method.Subsequently the patients were tested again using antigen test, which returned negative results, and then with pcr test, which also showed negative results.Bd quality performs a systematic approach to investigate all complaints.This approach involves review of manufacturing batch history records, review of software updates, testing of retention samples, and testing of customer returned samples, if applicable.Batch history record (bhr) review and retain sample testing could not be performed because a batch number was not provided.A review of bug fixes and software updates was conducted, and no issues related to this complaint were identified.This complaint cannot be confirmed.The root cause could not be identified.A trend analysis for false positive was conducted, no adverse trend was identified.Bd quality will continue to monitor for trends.H3 other text : see h.10.

• Brand Name: BD VERITOR ¿ AT-HOME COVID-19 TEST
• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17699980
• MDR Text Key: 322855041
• Report Number: 1119779-2023-00972
• Device Sequence Number: 1
• Product Code: QKP
• 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,Followup
• Report Date: 09/26/2023

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 Catalogue Number: 256094
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 09/12/2023; 09/12/2023
• Supplement Dates FDA Received: 09/15/2023; 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1