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

Catalog Number 256094

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that there was no information on the bd veritor¿ at-home covid-19 test box label that clarified a compatible cell phone must be used with an app to read the test results.There was no report of patient impact.(b)(4).The following information was provided by the initial reporter: "customer says she has several bd tests that she can not use.She says that there is no place on the box or on the amazon website that you must use a compatible cell phone and that you must use the app to read the results.".

Manufacturer Narrative

Medical device expiration date: unknown.The customer's address is unknown.(b)(6) usa has been used as a placeholder based on the reported phone area code.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

Correction: after further review, no incorrect label information was found.This is considered to be a cosmetic defect.This would require the user to acquire another component or a replacement to use the device as intended.This event could lead to a minor delay, but is unlikely to lead to serious injury.Therefore, the complaint will be cancelled.

Event Description

It was reported that there was no information on the bd veritor¿ at-home covid-19 test box label that clarified a compatible cell phone must be used with an app to read the test results.There was no report of patient impact.Eua# (b)(4) the following information was provided by the initial reporter: "customer says she has several bd tests that she can not use.She says that there is no place on the box or on the amazon website that you must use a compatible cell phone and that you must use the app to read the results.".

• 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: 13339140
• MDR Text Key: 286571101
• Report Number: 1119779-2022-00102
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

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: Other
• Device Catalogue Number: 256094
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/01/2022
• Initial Date FDA Received: 01/24/2022
• Supplement Dates Manufacturer Received: 04/01/2022
• Supplement Dates FDA Received: 04/01/2022
• 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