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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUIDELORTHO CORPORATION WALGREENS AT HOME COVID-19 TEST KIT
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QUIDELORTHO CORPORATION WALGREENS AT HOME COVID-19 TEST KIT Back to Search Results
Catalog Number 20460
Device Problems False Negative Result (1225); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/20/2024
Event Type  malfunction  
Manufacturer Narrative
Investigation conclusion: a review of complaint history did not identify any adverse trends for the reported issue for this lot.Root cause: insufficient information.Source: online review.
 
Event Description
Customer reporting 2 false negative sars results.Customer states the result was confirmed positive by pcr (unknown timeframe in between test results).Further contact with the customer is not possible.Report 2 of 2.
 
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Brand Name
WALGREENS AT HOME COVID-19 TEST KIT
Type of Device
WALGREENS AT HOME COVID-19 TEST KIT
Manufacturer (Section D)
QUIDELORTHO CORPORATION
10165 mckellar court
san diego CA 92121
Manufacturer Contact
karl luke
2005 east state street
athens, OH 45701
7405893382
MDR Report Key18846674
MDR Text Key337006114
Report Number0002024674-2024-00180
Device Sequence Number1
Product Code QKP
UDI-Device Identifier00311917122045
UDI-Public311917122045
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA203087
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number20460
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/20/2024
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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