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

Lot Number F415588

Device Problem False Positive Result (1227)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 11/03/2022

Event Type  malfunction  

Event Description

I had symptoms of a respiratory virus and took a few covid tests to check if it was that.The rapid antigen test quickvue (by quidel) came back positive (blue and red lines).Other rapid antigen tests (brands: abbott binaxnow, siemens clinitest) were negative.I read some anecdotal reports online that people had gotten false positives from quickvue, so with this conflicting information i got a pcr test the same morning.The pcr test was negative.I had cold-like symptoms but nothing as serious as (what i have heard described about) covid.Curious about this, and the reports of false positives, i tried out some more quickvue tests about a month later when i was not feeling any symptoms.I again got positive tests (and again got negative antigen test results from other brands).These quickvue tests seem to be everywhere for me: i got a december package of 2 from the usps, and a monthly batch of 8 from walgreens (free with my insurance).But they really seem to be faulty: i have never gotten a negative result when doing a nasal swab.I most recently tried again yesterday with the same result.Interestingly, i do not get a positive result from quickvue for any sort of "control" test: i tried water, saliva, and a throat swab; all resulted in negative tests.But the nasal swab is positive.Perhaps the test is sensitive to some other coronavirus? i haven't tried this out on other people, but plan to try.The box information for each test date was: (b)(6) 2022: lot f41005 (exp 2023-02-13); 2022-12-14: lot f41588 (exp 2023-05-12); 2023-01-19: lot 801602 (exp 2024-02-18); and lot n2e1901 (exp 2024-05-25) i have photos of the boxes and tests.On the (b)(6) date, i got two positive tests from nasal swabs, but three negative tests after swabbing: water, saliva, hands (i was experimenting with "controls").

• 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: 16233732
• MDR Text Key: 308080738
• Report Number: MW5114453
• 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: 01/20/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: F415588
• Patient Sequence Number: 1
• Treatment: OMEPRAZOLE
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White