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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 03/31/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation conclusion: a review of the dhr found that lot met all release criteria.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 (b)(4) false positive flu b result for (b)(4) patient, unknown whether symptomatic.Unknown whether 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 court
san diego CA 92121
Manufacturer Contact
karl luke
10165 mckellar court
san diego, CA 92121
7405893382
MDR Report Key14846381
MDR Text Key301650157
Report Number0002024674-2022-08262
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 06/28/2022
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 Number706409
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/31/2021
Initial Date FDA Received06/28/2022
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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