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U.S. Department of Health and Human Services

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

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QUIDEL CORP. QUICKVUE 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 09/22/2021
Event Type  malfunction  
Event Description
Our nephew took a quickvue covid test and received positive result. We saw him a few days earlier, so we also conducted the quickvue covid tests. Out of the test conducted on three family members, one came positive. We subsequently run a series of other tests and it turned out both our nephew's and our positive results were false. Before we've managed to figure it out, it caused a lot of commotion, stress, unnecessary quarantine, and cost a lot of money. Additionally, our nephew took both antigen and pcr test with healthcare provider and the whole family got tested, all with negative results.
 
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Brand NameQUICKVUE OTC COVID 19 TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
QUIDEL CORP.
MDR Report Key12614865
MDR Text Key276349785
Report NumberMW5104489
Device Sequence Number1
Product Code QKP
Combination Product (y/n)Y
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 10/07/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/08/2021 Patient Sequence Number: 1
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