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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 148866
Device Problems False Positive Result (1227); Product Quality Problem (1506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/27/2022
Event Type  malfunction  
Event Description
[quickvue at-home otc covid-19 test] use for covid-19 under emergency use authorization (eua): failure to meet performance specifications (including labeling claims) or failure to perform as intended - medical devices. Test purchased recently with expiration date of june 2023. The patient is my wife. I am emeritus professor of medicine at (b)(6) college of medicine. We had a recent possible exposure to someone with symptomatic covid; tested negative with binax test at 24 hours. My wife was asymptomatic. Re-tested with quickvue as above 5 days later. Result: positive. I, 72 years old, asymptomatic, also tested neg with binax at 24 hrs, on retest at 5 days, quickvue, same box, tested positive. That same day i repeated rat (rapid antigen test) with binax, it was neg. We both had pcr nasal swabs 5 hrs later. Both pcr tests negative. Hence the quickvue test for both of us was a false positive.
 
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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 Key15328043
MDR Text Key299184976
Report NumberMW5111811
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 Family Member or Friend
Type of Report Initial
Report Date 08/29/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot Number148866
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes

Patient Treatment Data
Date Received: 08/30/2022 Patient Sequence Number: 1
Treatment
BINAX NOW COVID TEST
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