MAUDE Adverse Event Report: QUIDELORTHO CORPORATION SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB

Catalog Number 20377

Device Problems No Apparent Adverse Event (3189); Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2023

Event Type  malfunction  

Event Description

Customer reporting that a new employee during training accidently swabbed another employee in the nose using a positive control swab (swab is coated with non-infectious recombinant flu a, flu b, and sars antigens).Employee was immediately tested for sofia flu+sars and tested negative for all targets (flu a, b, sars).Employee has not experienced any symptoms or adverse reactions to date.

Manufacturer Narrative

Investigation summary: 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: SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB
• Type of Device: SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB
• Manufacturer (Section D): QUIDELORTHO CORPORATION; 10165 mckellar court; san diego CA 92121
• Manufacturer Contact: karl luke ; 10165 mckellar court; san diego, CA 92121
• MDR Report Key: 17981277
• MDR Text Key: 326358075
• Report Number: 0002024674-2023-01801
• Device Sequence Number: 1
• Product Code: QMN
• UDI-Device Identifier: 30014613339229
• UDI-Public: 30014613339229
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA202751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 20377
• Device Lot Number: 708405
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1