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

Catalog Number 20377

Device Problems No Apparent Adverse Event (3189); Non Reproducible Results (4029)

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

Event Date 11/03/2023

Event Type  malfunction  

Event Description

Customer reporting discordant flu b result.Customer states the patient was flu b positive on a friday and when retested on saturday was negative.No confirmation testing was performed and symptomatic status is unknown.

Manufacturer Narrative

Investigation summary: a review of the dhr found that the lot met all release criteria.A review of complaint history did not identify any adverse trends for the reported issue for this lot.Tested 5x returned devices with negative standard.All devices yielded valid and accurate negative results at the 15 minute result read time.Root cause: unable to duplicate with customer return kit.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: 18271390
• MDR Text Key: 329807583
• Report Number: 0002024674-2023-01970
• 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: 12/05/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 20377
• Device Lot Number: 708967
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 12/05/2023
• 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