MAUDE Adverse Event Report: QUIDEL CORP. QUICKVUE AT-HOME OTC COVID-19 TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number N1J2201

Device Problem Inadequate Instructions for Non-Healthcare Professional (2956)

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

Event Date 12/31/2021

Event Type  malfunction  

Event Description

The product was the quidel quickvue at-home otc covid-19 test.The problem relates to package insert instructions for interpreting the test.Step 11 clearly states, "a negative result will show a blue line but no pink line." in other words, a test should be considered positive if there is a pink line.However this is not accurate.In the normal use of the test a pink line can appear and the test should be interpreted as negative as per the company's faqs that are published on their website.After searching the internet, i found the below "if i see pink shading on the strip bordering the black label, is this a positive result? only a pink line about half of a centimeter below the blue control line should be considered a positive result.A pink line bordering the black label with the arrows, a vertical pink line, or a faint grey line next to the blue control line is not considered a positive test line and should not be called a positive result." there is also a diagram showing the various lines and how to interpret.If not a design flaw, that at minimum, the package insert is misleading and needs to change.The information in the faqs should be in the package insert.There is no reference to this phenomenon in the package insert.A patient should not have to have access to, and search the internet for how to interpret this test.(b)(4).Fda safety report id # (b)(4).

• Brand Name: QUICKVUE AT-HOME OTC COVID-19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 13251031
• MDR Text Key: 283845975
• Report Number: MW5106618
• 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: 01/10/2022

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 Expiration Date: 10/23/2023
• Device Lot Number: N1J2201
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2022
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White