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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 Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation conclusion: tested 5x retained devices with negative standard.All devices yielded valid and accurate negative results at the 15 minute result read time.Root cause: could not duplicate with retains.Source: email.
 
Event Description
Reported multiple false positive flu results on sofia flu+sars.Unknown whether it was on flu a or flu b.Patient is asymptomatic.Unknown if the result was confirmed.Confirmation method(s) not provided.
 
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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 ct.
san diego CA 92121
Manufacturer Contact
karl luke
10165 mckellar ct.
san diego, CA 92121
7405893382
MDR Report Key14476750
MDR Text Key292488185
Report Number0002024674-2022-04735
Device Sequence Number1
Product Code QMN
UDI-Device Identifier30014613339229
UDI-Public30014613339229
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 05/20/2022
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 Number706436
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/01/2021
Initial Date FDA Received05/23/2022
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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