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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUIDELORTHO CORPORATION SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB
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QUIDELORTHO CORPORATION SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB Back to Search Results
Catalog Number 20377
Device Problems No Apparent Adverse Event (3189); Non Reproducible Results (4029)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/07/2023
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: a review of the dhr found that the lot met all release criteria.A review of complaint history did not identify any adverse trends for the reported issue for this lot.Root cause: unable to determine source: phone.
 
Event Description
Customer reporting 1 discordant flu b result.Customer states the patient was flu b positive on a thursday and when retested on saturday was negative.No confirmation testing was performed and symptomatic status is unknown.
 
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Brand Name
SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB
Type of Device
SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB
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 Key18268935
MDR Text Key329746788
Report Number0002024674-2023-01969
Device Sequence Number1
Product Code QMN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA202751
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 12/05/2023
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 Health Professional
Device Catalogue Number20377
Device Lot Number708958
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/07/2023
Initial Date FDA Received12/05/2023
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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