MAUDE Adverse Event Report: QUIDEL CORPORATION SOFIA SARS ANTIGEN FIA, NS SWAB

Catalog Number	20374
Medical Device Problem Codes	False Positive Result (1227); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: a review of complaint history did not identify any adverse trends.Root cause: insufficient information.Source: email.
Event or Problem Description
Reported false positive sars results for an unknown number of patients.It is unknown if the patients were symptomatic or if confirmatory testing was performed.Multiple attempts were made to contact the customer for more information.The customer was unresponsive.

• Brand Name: SOFIA SARS ANTIGEN FIA, NS SWAB
• Common Device Name: SOFIA SARS ANTIGEN FIA, NS SWAB
• Manufacturer (Section D): QUIDEL CORPORATION; 10165 mckellar ct.; san diego CA 92121
• Manufacturer Contact: karl luke ; 10165 mckellar court; san diego, CA 92121 ; 7405893382
• MDR Report Key: 16877964
• Report Number: 0002024674-2023-01214
• Device Sequence Number: 12219899
• Product Code: QKP
• UDI-Device Identifier: 30014613339083
• UDI-Public: 30014613339083
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EUA200742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 20374
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 05/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown