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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUIDELORTHO CORPORATION QUICKVUE SARS ANTIGEN TEST
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QUIDELORTHO CORPORATION QUICKVUE SARS ANTIGEN TEST Back to Search Results
Catalog Number 20387
Device Problems False Negative Result (1225); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2024
Event Type  malfunction  
Event Description
Customer reporting what they feel was a potential false negative sars result.Customer was confirmed covid positive and treated with paxlovid.Customer was sars negative on this test 1 week after paxlovid treatment started but was positive when testing again after patient became re-symptomatic 10 days later (possible re-bound).Customer tested negative 3 days after re-bound positive (suspected false negative) but then tested positive again when testing two days later.
 
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: email.
 
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Brand Name
QUICKVUE SARS ANTIGEN TEST
Type of Device
QUICKVUE SARS ANTIGEN 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 Key19146910
MDR Text Key341365892
Report Number0002024674-2024-00240
Device Sequence Number1
Product Code QKP
UDI-Device Identifier30014613339373
UDI-Public30014613339373
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA203086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/18/2024
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 Number20387
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/19/2024
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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