MAUDE Adverse Event Report: QUIDEL CORP. SOFIA SARS ANTIGEN FIA; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Test Result (2695)

Event Date 07/29/2020

Event Type  malfunction  

Event Description

Went to get covid test, the clinic gave me a positive result, i knew i was not positive as i have antibodies from previous positive case and then i went back two hours later and i had a negative test result.This test should not be used and needs better controls.It provides false results which have implications on public policy.Fda safety report id# (b)(4).

• Brand Name: SOFIA SARS ANTIGEN FIA
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 10355540
• MDR Text Key: 201535037
• Report Number: MW5095829
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR