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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
Model Number 20402
Device Problems No Apparent Adverse Event (3189); Erratic Results (4059)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2022
Event Type  malfunction  
Event Description
Reported conflicting sars results for 1 consumer.It is unknown if the consumer was symptomatic.The consumer communicated that they received 2 positive quickvue otc results and 1 negative result 4 days later without any further confirmation testing.Each event is captured on a separate report.
 
Manufacturer Narrative
Investigation conclusion: a review of the dhr found that the lot met all release criteria.A review of complaint history did not identify any adverse trends.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 ct.
san diego CA 92121
Manufacturer Contact
karl luke
10165 mckellar ct.
san diego, CA 92121
7405893382
MDR Report Key16060482
MDR Text Key307726426
Report Number0002024674-2022-10689
Device Sequence Number1
Product Code QKP
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 12/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number20402
Device Catalogue Number20402
Device Lot Number3672136
Date Manufacturer Received12/13/2022
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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