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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUIDEL CORP QUICKVUE AT HOME COVID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
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QUIDEL CORP QUICKVUE AT HOME COVID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  malfunction  
Event Description
Spouse lost sense of smell.Conducted quickvue at home covid test, which reported positive.To confirm, conducted binaxnow at home covid test, which reported negative.Conducted one more quickvue covid test, also reported positive.Two (2) days later, had molecular test conducted at local (b)(6) (id now, rapid diagnostic test), results reported negative.Conducted one more quickvue covid test, results reported positive.The next day, conducted one more binaxnow, results negative.We understand that molecular tests are supposed to be more accurate, but these mixed test results are confusing on my work schedule and our interactions with our children.In summary: (b)(6) 2021 lost sense of smell positive quickvue test, negative binaxnow test, positive quickvue test, (b)(6) 2021 negative id now rapid diagnostic test (molecular), positive quickvue test (b)(6) 2021, negative binaxnow test.Fda safety report id # (b)(4).
 
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Brand Name
QUICKVUE AT HOME COVID TEST
Type of Device
CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
QUIDEL CORP
MDR Report Key12568656
MDR Text Key274721584
Report NumberMW5104330
Device Sequence Number3
Product Code QKP
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 09/29/2021
6 Devices were Involved in the Event: 1   2   3   4   5   6  
1 Patient was Involved in the Event
Date FDA Received10/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age41 YR
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