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 08/17/2022

Event Type  malfunction  

Event Description

It was reported by the customer that they had discrepant results with bd veritor ¿ at-home covid-19 test.There was one occurrence in this event with no patient impact.The following information was provided by the customer: "the customer went to the doctor, she tested positive 11 days ago the she used another test and tested negative using a different vendor five days ago and just tested using our test.She wanted to know why the different results.The customer wanted to know why another test came out negative but bd test still show she's positive.".

Manufacturer Narrative

Address information was not able to be obtained, therefore, md was used as a place holder.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: this summarizes the investigation results regarding a complaint that alleges ¿discrepant results¿ using the bd veritor at home covid-19 test (material # 256094), batch number 2031999.Bd quality performs a systematic approach to investigate all complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation and testing were performed on the batch number provided.Results were acceptable and no relevant issue was found.The complaint was unable to be confirmed.The root cause could not be identified.Currently, there are no adverse trends identified for discrepant results.Bd quality will continue to monitor for trends.

Event Description

It was reported by the customer that they had discrepant results with bd veritor ¿ at-home covid-19 test.There was one occurrence in this event with no patient impact.The following information was provided by the customer: "the customer went to the doctor, she tested positive 11 days ago the she used another test and tested negative using a different vendor five days ago and just tested using our test.She wanted to know why the different results.The customer wanted to know why another test came out negative but bd test still show she's positive.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15323634
• MDR Text Key: 302112396
• Report Number: 1119779-2022-01154
• 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: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/26/2022
• Device Catalogue Number: 256094
• Device Lot Number: 2031999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• 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