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

Catalog Number 20377

Device Problems False Negative Result (1225); No Apparent Adverse Event (3189)

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

Event Date 03/11/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: to be determined.Root cause: to be determined.Source: email.Additional information will be included in a follow-up report upon completion of the investigation.

Event Description

Customer reporting false negative flu b results on 8 symptomatic patients out of 180 patients tested.Customer states the results were positive by pcr.Report 7 of 8.

Manufacturer Narrative

Updates made: b4; date of report ; updated to today's date h6; type of investigation codes ; investigation findings codes ; investigation conclusion codes 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 3x customer returned devices with flu a positive standard and 3x retained devices with flu b positive standard.All devices yielded valid and accurate results at the 15 minute result read time.Root cause:can not determine with customer return kit testing source: email.

• 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: 19085543
• MDR Text Key: 340575560
• Report Number: 0002024674-2024-00237
• 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,Followup
• Report Date: 05/22/2024

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: 709258
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2024
• 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