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

Catalog Number	20374
Medical Device Problem Codes	No Apparent Adverse Event (3189); Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
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: phone.
Event or Problem Description
Reported conflicting sars results for 1 symptomatic patient.The customer communicated that the patient first tested negative and then later positive when retesting using a different sofia analyzer.No confirmatory testing had been completed.

• 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: 17345649
• Report Number: 0002024674-2023-01538
• Device Sequence Number: 6488402
• Product Code: QKP
• UDI-Device Identifier: 30014613339083
• UDI-Public: 30014613339083
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/18/2023

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: 06/19/2023
• Initial Report FDA Received Date: 07/18/2023
• 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