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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUIDEL CORPORATION SOFIA SARS ANTIGEN FIA, NS SWAB
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QUIDEL CORPORATION SOFIA SARS ANTIGEN FIA, NS SWAB Back to Search Results
Catalog Number 20374
Device Problems False Negative Result (1225); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2022
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 false negative result for 1 patient.It is unknown if the patient was symptomatic.The customer communicated the result was confirmed positive by molecular (pcr testing).The customer was unable to provide further details and clarification.
 
Manufacturer Narrative
Correction: please remove all information from this report number as it was submitted in error.
 
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Brand Name
SOFIA SARS ANTIGEN FIA, NS SWAB
Type of Device
SOFIA 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 Key15681394
MDR Text Key304913722
Report Number0002024674-2022-10203
Device Sequence Number1
Product Code QKP
UDI-Device Identifier30014613339083
UDI-Public30014613339083
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA200742
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,Followup
Report Date 10/27/2022
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 Number20374
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/04/2022
Initial Date FDA Received10/27/2022
Supplement Dates Manufacturer Received10/04/2022
Supplement Dates FDA Received11/18/2022
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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