MAUDE Adverse Event Report: QUIDEL CORP. SOFIA ANTIGEN TEST FOR COVID19; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2020

Event Type  malfunction  

Event Description

(b)(6) is issuing antigen negative test results with misleading language at the bottom of the results sheet that is not in alignment with the patient insert from quidel.It overstates the tests accuracy, says the patient is not contagious, and does include the required language from quidel advising about possible false negatives and that the patient could still have covid.This is giving people a false sense of security from a test that had only 209 tests to get emergency approval.This is irresponsible and dangerous, and the clinic should be including the necessary language.Fda safety report id# (b)(4).

• Brand Name: SOFIA ANTIGEN TEST FOR COVID19
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 10395850
• MDR Text Key: 202723808
• Report Number: MW5096001
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1