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U.S. Department of Health and Human Services

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

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QUIDEL CORP. QUIDEL QUICKVUE AT HOME OTC COVID-19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Device Problem False Positive Result (1227)
Patient Problem Emotional Changes (1831)
Event Date 12/08/2021
Event Type  malfunction  
Event Description
I took 3 quidel at home covid tests on (b)(6) and (b)(6) which all showed faint positive results after i had a stomach bug and fever the previous day. My entire family had to quarantine due to thinking i had covid. I got a pcr test on (b)(6) and did not receive results until (b)(6) that the test was negative. I had to stay home the whole week from work, using my own sick leave and keep my kids joke from school while still having to pay their daycare costs out of pocket. We had to miss all extracurricular activities. I was emotionally distraught waiting on pcr test results. The rest of the family tested negative and their pcr results came back much faster. This false positive from this brand of at home test negatively impacted my finances, mental health, and entire family. I took a binax at home test on (b)(6) and (b)(6) while waiting for my results which both showed negative. I believe this brand should be researched for false positive results. I am embarrassed and i can't get the time back from work or school for the kids. This was the same result of 3 tests taken over 2 days. My husband took the 4th test we had and his was negative. Covid test due to symptoms.
 
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Brand NameQUIDEL QUICKVUE AT HOME OTC COVID-19 TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
QUIDEL CORP.
MDR Report Key13011723
MDR Text Key282397008
Report NumberMW5106058
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 12/12/2021
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 12/14/2021 Patient Sequence Number: 1
Treatment
DAILY VITAMIN
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