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U.S. Department of Health and Human Services

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

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QUIDEL CORP. QUICKVUE AT-HOME OTC COVID-19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Lot Number F40162
Device Problem False Negative Result (1225)
Patient Problem Anxiety (2328)
Event Date 12/24/2021
Event Type  malfunction  
Event Description
I wanted to take a rapid covid test before going to a friend's for christmas eve dinner, and used a quickvue test. I waited until shortly before i planned on leaving, and carefully followed the instructions included in the box. The instructions stated that even a very faint pink line indicated a positive test result. Because of the poor design of the test, the pink line that would activate was faintly visible. Because it didn't seem quite right, i called my boyfriend who had taken the same brand of test the day before. He also reported seeing a faint pink line "if you squint," but that it was clear it hadn't "activated. " in other words, we both had the experience of being able to see the line where it would appear/"activate" for a positive result. I followed up with a different test brand (ihealth). The ihealth test returned an unambiguous negative result, and i went to the small christmas eve gathering. However, and herein lies the problem, the quickvue results kept bothering me. After going to a christmas day movie and a small group dinner, i woke up at 5 a. M. Convinced that i had covid, and could be responsible for transmitting it to the people i spent christmas eve and christmas day with. I repeated an ihealth test and got negative results, which were confirmed later in the day with a curative pcr test. I understand that rapid antigen tests are in short supply, but i think the fda should take a closer look at the usability of the quickvue test and ask that the company make improvements. A false positive is certainly better than a false negative, but it causes anxiety. Via social media, i know of at least one other person who had a similar experience. Fda safety report id# (b)(4).
 
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Brand NameQUICKVUE AT-HOME OTC COVID-19 TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
QUIDEL CORP.
MDR Report Key13141571
MDR Text Key283153903
Report NumberMW5106392
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/29/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot NumberF40162
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 12/30/2021 Patient Sequence Number: 1
Treatment
ADVIL ; ATENOLOL; ATORVASTATIN ; D-MANNOSE + CRANBERRY; DAILY VITAMIN ; NEXIUM (AT TIME OF TEST) ; ORAL CONTRACEPTIVES; VITAMIN D
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