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

Catalog Number 20377

Device Problems No Apparent Adverse Event (3189); Erratic Results (4059)

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

Event Date 12/12/2022

Event Type  malfunction  

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 Description

Reported discrepant flu a/b result for 1 symptomatic patient/provider.The provider tested themselves 3 times after recently being exposed to a relative who had tested positive for flu b.The provider communicated that they tested positive for flu a on the first test, positive for flu b on the second, and negative for both flu a/b on the third.It was reported that the provider tested after not properly calibrating the instrument and not passing controls.Each event is captured on a separate report.

• Brand Name: SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB
• Type of Device: SOFIA2 FLU + 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: 16060031
• MDR Text Key: 306801040
• Report Number: 0002024674-2022-10686
• Device Sequence Number: 1
• Product Code: QMN
• 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: 12/28/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 20377
• Device Lot Number: 708253
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/28/2022
• 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