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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUIDEL CORPORATION SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB
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QUIDEL CORPORATION SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB Back to Search Results
Catalog Number 20377
Device Problems False Positive Result (1227); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2022
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.Root cause: unable to determine.Source: email.
 
Event Description
Customer reporting 1 false positive sars result.Customer states the result was confirmed negative for sars by pcr but positive for flu by additional method.Patient is under the age of 3, was symptomatic with cough and congestion, no fever.
 
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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)
QUIDEL CORPORATION
10165 mckellar court
san diego CA 92121
Manufacturer Contact
karl luke
10165 mckellar court
san diego, CA 92121
7405893382
MDR Report Key16065139
MDR Text Key307584348
Report Number0002024674-2022-10546
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 12/28/2022
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 Number708253
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/01/2022
Initial Date FDA Received12/28/2022
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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