MAUDE Adverse Event Report: QUIDELORTHO CORPORATION SOFIA SARS ANTIGEN FIA, NS SWAB

Catalog Number 20374

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

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

Event Date 10/11/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a review of complaint history did not identify any adverse trends.Root cause: insufficient information.Source: phone.

Event Description

Customer reporting 4 conflicting sars results.Customer states the results were positive on one instrument but negative when run on another instrument.Report 4 of 4.

• Brand Name: SOFIA SARS ANTIGEN FIA, NS SWAB
• Type of Device: SOFIA SARS ANTIGEN FIA, NS SWAB
• Manufacturer (Section D): QUIDELORTHO CORPORATION; 10165 mckellar court; san diego CA 92121
• Manufacturer Contact: karl luke ; 2005 east state street; san diego, CA 45701
• MDR Report Key: 17966294
• MDR Text Key: 326057410
• Report Number: 0002024674-2023-01790
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 30014613339229
• UDI-Public: 30014613339229
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA200742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,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: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20374
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• 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