MAUDE Adverse Event Report: QUIDEL 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 06/19/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reported conflicting sars results for 1 symptomatic patient.The customer communicated that the patient first tested negative and then later positive when retesting using a different sofia analyzer.No confirmatory testing had been completed.

• Brand Name: SOFIA SARS ANTIGEN FIA, NS SWAB
• Type of Device: SOFIA SARS ANTIGEN FIA, NS SWAB
• Manufacturer (Section D): QUIDEL CORPORATION; 10165 mckellar ct.; san diego CA 92121
• Manufacturer Contact: karl luke ; 10165 mckellar court; san diego, CA 92121 ; 7405893382
• MDR Report Key: 17345649
• MDR Text Key: 319837081
• Report Number: 0002024674-2023-01538
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 30014613339083
• UDI-Public: 30014613339083
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/18/2023

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: 20374
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/18/2023
• 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