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

Catalog Number 256094

Device Problem Patient Data Problem (3197)

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

Event Date 01/18/2022

Event Type  malfunction  

Event Description

It was reported that while testing with the bd veritor ¿ at-home covid-19 test, the customer created a minor account and began testing.During the 15 minute incubation window the customer experienced a power failure on their mobile device.The customer powered the mobile device back on prior to the expiration of the incubation window and successfully scanned the test device.The customer realized after scanning the test device that the result was associated with the primary account owner instead of the minor account.There was no report of patient impact.(b)(4).The following information was provided by the initial reporter: customer states that her phone died in the middle of taking the test when she turned it back on the test timer was still going and now the positive result it got is under her profile and not the account she was signed into.

Manufacturer Narrative

(b)(4).Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Manufacturer Narrative

Investigation summary: this statement is to summarize the investigation of a complaint involving the veritor at home device kit (product number 256094), lot unknown.According to information provided, while testing under a minor's profile, the phone ¿died¿ during the 15 minute timer.When the user rebooted the phone and re-launched the app, it took them back to the timer screen and they scanned for the result.Later, the user noted that the test result had been linked to their (account owner's) profile, and not the profile of the minor being tested.Bd quality performs a systematic approach to investigate all complaints.This approach involves review for adverse trends and working in conjunction with the app developer where applicable.Investigation found that the reported situation was related to a rare software bug specific to ios devices.Under certain rare conditions the test subject (user) profile may convert to ¿nil¿.If the app encounters the ¿nil¿ profile value when the test result is complete, it may associate the test result with the account owner¿s profile instead of the actual test subject profile.In this case, that occurred when the phone in use was re-booted and the app was relaunched prior to the result scan.Ios app update v1.4 was incorporated to eliminate the potential for the "nil" profile situation to occur.This report is assessed as unconfirmed for any associated product quality issues and there is no impact on the safety or efficacy of the product.Additionally, no new hazards or risks were identified during this evaluation.Bd continues to monitor all reports of this type, as well as for any associated trends.Currently no adverse trend for reports of this type have been identified.If you have any additional questions or concerns, please do not hesitate to contact bd technical services.

Event Description

It was reported that while testing with the bd veritor ¿ at-home covid-19 test, the customer created a minor account and began testing.During the 15 minute incubation window the customer experienced a power failure on their mobile device.The customer powered the mobile device back on prior to the expiration of the incubation window and successfully scanned the test device.The customer realized after scanning the test device that the result was associated with the primary account owner instead of the minor account.There was no report of patient impact.(b)(4).The following information was provided by the initial reporter: customer states that her phone died in the middle of taking the test when she turned it back on the test timer was still going and now the positive result it got is under her profile and not the account she was signed into.

• 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: 13546248
• MDR Text Key: 286499018
• Report Number: 1119779-2022-00251
• 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,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

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: Lay User/Patient
• 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: 01/18/2022
• Initial Date FDA Received: 02/16/2022
• Supplement Dates Manufacturer Received: 08/24/2022
• Supplement Dates FDA Received: 09/01/2022
• 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