MAUDE Adverse Event Report: BECTON DICKINSON & COMPANY VERITOR; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem Application Program Version or Upgrade Problem (2881)

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

Event Date 07/30/2022

Event Type  malfunction  

Event Description

Covid test requires app, but could not determine until after getting test that phone was not compatible so now i will have to go to the clinic to get tested.Test app required my name and email and date of birth before i could determine phone was not compatible.This is a horrible product and should not be available because people need to have a reliable test at home.Fda safety report id# (b)(4).

• Brand Name: VERITOR
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): BECTON DICKINSON & COMPANY
• MDR Report Key: 15155893
• MDR Text Key: 297221803
• Report Number: MW5111229
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/30/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2022
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White