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

Device Problems False Negative Result (1225); Missing Information (4053)

Patient Problem Viral Infection (2248)

Event Date 10/02/2022

Event Type  Injury  

Event Description

I used a "quickvue at-home otc covid-19 test" and it appeared negative.I assumed i was and exposed my family to covid.When i came back to this test that i had left out, i peeled off a sticker with arrows on it pointing to the test end of the test strip and found that the sticker was covering the positive pink test line.I took the second test in the box and the same thing happened.The positive pink test line was obscured by the arrow sticker.I've include photos of before and after i peeled the sticker off the second test.I also took a photo of unit information.This defective test means the people testing positive don't know they are because the sticker covers the result.Most people won't look under the sticker, no where do the instructions say to do this.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 CORPORATION
• MDR Report Key: 15542886
• MDR Text Key: 301243003
• Report Number: MW5112409
• Device Sequence Number: 2
• 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: 10/03/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 180 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White