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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUIDELORTHO CORPORATION QUICKVUE AT-HOME OTC COVID-19 TEST
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QUIDELORTHO CORPORATION QUICKVUE AT-HOME OTC COVID-19 TEST Back to Search Results
Catalog Number 20402
Device Problems False Positive Result (1227); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2024
Event Type  malfunction  
Manufacturer Narrative
Investigation conclusion: a review of the product did not find any unusual trend for the reported complaint category.Root cause: insufficient information.Source: website.
 
Event Description
Customer reporting testing continually sars false positive when using this test.Customer states they are negative by pcr and other rapid antigen tests.Numerous attempts were made to understand how many tests were taken by the customer but were unsuccessful.Two reports will be filed for unknown number.Report 2 of 2.
 
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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)
QUIDELORTHO CORPORATION
10165 mckellar court
san diego CA 92121
Manufacturer Contact
karl luke
10165 mckellar court
san diego, CA 92121
MDR Report Key19038294
MDR Text Key339335962
Report Number0002024674-2024-00212
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 04/03/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number20402
Initial Date Manufacturer Received 03/07/2024
Initial Date FDA Received04/03/2024
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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