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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported false positive sars result for 1 patient.It is unknown if the patient was symptomatic.The customer communicated the result was confirmed negative by molecular (pcr testing).It was reported that the customer had been using remel m4-rt utm as well as third party swabs (off-label use) to run the tests.
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.

• 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 ct.; san diego, CA 92121 ; 7405893382
• MDR Report Key: 16482952
• Report Number: 0002024674-2023-00656
• Device Sequence Number: 7482166
• Product Code: QKP
• UDI-Device Identifier: 30014613339083
• UDI-Public: 30014613339083
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/03/2023

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
• Device Lot Number: 706634
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 03/03/2023
• 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