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U.S. Department of Health and Human Services

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

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QUIDEL CORP. QUICKVUE AT-HOME COVID-19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Lot Number 3655546
Device Problem False Positive Result (1227)
Patient Problem Emotional Changes (1831)
Event Date 11/12/2021
Event Type  malfunction  
Event Description
I took 3 otc covid tests over 3 days. All were quidel quickvue at-home covid-19 test. They were all from different boxes. I followed the directions exactly (i have a phd in chemistry and know how to be careful with laboratory testing). I received positive results from each of the 3 tests. After each tests, i went and received a pcr tests from 3 different sources; all 3 of these pcr tests were negative. Family members took the second test available in two of the boxes and both of those tests were negative. I clearly had something that was triggering the false positive result for the quickvue tests. Based on the results of the quickvue tests, i canceled a number of personal commitments, including one which incurred a (b)(6) cancellation fee. I also pulled one child from school and isolated from my family for 2 days until the second pcr test returned a negative result. Tests were conducted on (b)(6) 2021. Fda safety report id # (b)(4).
 
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Brand NameQUICKVUE AT-HOME COVID-19 TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
QUIDEL CORP.
MDR Report Key12834949
MDR Text Key281009743
Report NumberMW5105400
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 11/15/2021
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received11/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot Number3655546
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 11/17/2021 Patient Sequence Number: 1
Treatment
MONTELUKAST; MULTIVITAMIN; PROBIOTICS; PROTONIX; RESTASIS; VITAMIN D3
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