MAUDE Adverse Event Report: QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS 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	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: a review of the package insert (pi) was conducted for clarity of instructions.No issues were found.The customer's reported problem was related to a deviation from the instructions called out in the pi.Root cause: customer procedural error.Source: phone.
Event or Problem Description
Inconsistent sars results reported.Customer received one positive and one negative result, customer does not allow proper extraction time.Unknown is symptomatic or asymptomatic.Unknown if the result was confirmed.Report 2 of 2.

• Brand Name: SOFIA SARS ANTIGEN FIA, NS SWAB
• Common Device Name: SOFIA SARS ANTIGEN FIA, NS SWAB
• Manufacturer (Section D): QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS; 10165 mckellar court; san diego CA 92121
• Manufacturer Contact: chelsea lindgren ; 10165 mckellar court; san diego, CA 92121
• MDR Report Key: 20434481
• Report Number: 0002024674-2024-00525
• Device Sequence Number: 18049075
• Product Code: QKP
• UDI-Device Identifier: 30014613339083
• UDI-Public: 30014613339083
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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

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
• Device Lot Number: 709207
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 10/11/2024
• 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