MAUDE Adverse Event Report: BECTON DICKINSON & CO. BD VERITOR AT-HOME COVID-19 TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 1094952

Device Problems Product Quality Problem (1506); Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 01/19/2022

Event Type  malfunction  

Event Description

Purchased bd veritor covid-19 test on (b)(6) because everything else was sold out.Tried to interpret it without using its app; did not realize it had an extra control line; misread negative result as positive result.This was almost entirely my own fault.However, i am not the only person who made this mistake: (b)(6) reviews indicate other customers have made the same assumption, based on how other at-home tests work (control + test line).Product package was accurate and instructions were not in any way misleading, but, product package was not my only source of information.Test result would have been read as negative by the (b)(6) app; i attempted to read it visually, without the app, and misinterpreted it as positive (based on prior experience with other take-home tests, and lacking guidance from the test manufacturer on how to interpret visually).Fda safety report id# (b)(4).

• Brand Name: BD VERITOR AT-HOME COVID-19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): BECTON DICKINSON & CO.
• MDR Report Key: 13358178
• MDR Text Key: 284621665
• Report Number: MW5106956
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/02/2023
• Device Lot Number: 1094952
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 155 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White