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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUIDEL CORPORATION QUICKVUE SARS ANTIGEN TEST
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QUIDEL CORPORATION QUICKVUE SARS ANTIGEN TEST Back to Search Results
Catalog Number 20387
Device Problems No Apparent Adverse Event (3189); Erratic Results (4059)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2022
Event Type  malfunction  
Manufacturer Narrative
Investigation conclusion: a review of complaint history did not identify any adverse trends.Root cause: insufficient information.Source: phone.
 
Event Description
Reported discrepant sars results for an unknown total number of asymptomatic patients.The customer communicated that some patients have tested with quickvue sars multiple times or have followed up with confirmation testing and received a different result.Attempts were made to contact the customer for more information.The customer was unable to provide further details and clarification.
 
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Brand Name
QUICKVUE SARS ANTIGEN TEST
Type of Device
QUICKVUE SARS ANTIGEN 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 Key16072832
MDR Text Key307726972
Report Number0002024674-2022-10702
Device Sequence Number1
Product Code QKP
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 Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number20387
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/16/2022
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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