MAUDE Adverse Event Report: BD RAPID DIAGNOSTICS (SUZHOU) CO. LTD. VERITOR AT-HOME COVID-19 DIGITAL TEST KIT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problems False Positive Result (1227); Product Quality Problem (1506); Device Markings/Labelling Problem (2911)

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

Event Date 05/04/2022

Event Type  Injury  

Event Description

Tuesday(b)(6) i had a sore throat and took a rapid antigen covid test swabbing my throat and my nose.The test came back very faintly positive.My symptoms (sore throat, head ache, tiredness) worsened from tuesday to wednesday.To ensure the throat swab was not a false positive i took an additional test the following day (wednesday (b)(6)) just swabbing my nose.This test returned two clear lines, and based on this result my primary care physician prescribed a course of paxlovid during a zoom call.I learned today - from (b)(6) product reviews - that the second covid test i took, a bd veritor, actually requires three lines for a positive test.And so i was negative for covid-19 the day i was prescribed a course of paxlovid.This mistake likely happened for the following reasons: i never purchased the bd veritor - it was provided by the government as part of the free covid test program so was unfamiliar with the ridiculous requirements to interpret the results; there are several versions of the test that have a different number and type of control strips.The interpretation requires a smart phone to read a bar code to clarify which control strips are in the test.Not every smart phone will work with this, and also the program to use it is annoying and does not let you skip the video; there are no instructions for how to interpret the results without a smartphone (this is ridiculous and the reason these tests are priced at a (b)(4) discount on (b)(4), and probably why the government had a surplus and was sending them.There is not even marking on the test to indicate where the control strips are - this is unusual for lateral flow covid tests.Since the (b)(6) 2021 eua for the bd veritor there have been several changes to the world which i think merit a re-evaluation of the eua for this device as it currently is designed and packaged.At home covid treatments like paxlovid are not available, raising the risks for false positive interpretation significantly.Government and health insurance programs to provide "free" lateral flow tests mean that all approved devices are being used with limited market pressure or understanding of additional device requirements.Fda safety report id#:(b)(4).

• Brand Name: VERITOR AT-HOME COVID-19 DIGITAL TEST KIT
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): BD RAPID DIAGNOSTICS (SUZHOU) CO. LTD.
• MDR Report Key: 14407861
• MDR Text Key: 291947923
• Report Number: MW5109690
• 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: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 05/13/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White