MAUDE Adverse Event Report: QUIDEL CORP. SOFIA 2 ANTIGEN FIA; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number SPECIMEN ID 00-415319-06

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 12/21/2020

Event Type  malfunction  

Event Description

On (b)(6) 2020, i received a false positive test result from a rapid covid-19 test i had done at a clinic through (b)(6).I took a pcr test the next day and those test results were negative.The tests were done 14 hours apart.Fda safety report id# (b)(4).

• Brand Name: SOFIA 2 ANTIGEN FIA
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 11107903
• MDR Text Key: 225081337
• Report Number: MW5098609
• Device Sequence Number: 1
• Product Code: QKP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPECIMEN ID 00-415319-06
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 66