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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUIDEL CORPORATION QUICKVUE AT-HOME OTC COVID-19 TEST
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QUIDEL CORPORATION QUICKVUE AT-HOME OTC COVID-19 TEST Back to Search Results
Catalog Number 20402
Device Problems No Apparent Adverse Event (3189); Non Reproducible Results (4029)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/24/2023
Event Type  malfunction  
Event Description
Customer reporting 2 conflicting sars results.Customer states the results were positive by qv at-home otc but negative by another brand rapid antigen test.Patient has been symptomatic for 1 day.No confirmation testing has been performed.Report 1 of 2.
 
Manufacturer Narrative
Investigation conclusion: a review of the dhr found that the lots met all release criteria.A review of complaint history did not identify any adverse trends for the reported issue for these lots.Root cause: unable to determine.Source: phone.
 
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Brand Name
QUICKVUE AT-HOME OTC COVID-19 TEST
Type of Device
QUICKVUE AT-HOME OTC COVID-19 TEST
Manufacturer (Section D)
QUIDEL CORPORATION
10165 mckellar court
san diego CA 92121
Manufacturer Contact
karl luke
10165 mckellar court
san diego, CA 92121
7405893382
MDR Report Key17656376
MDR Text Key322735338
Report Number0002024674-2023-01608
Device Sequence Number1
Product Code QKP
UDI-Device Identifier30014613339724
UDI-Public30014613339724
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA210269
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number20402
Device Lot Number2206005
Date Manufacturer Received08/24/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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