MAUDE Adverse Event Report: QUICKVUE RAPID ANTIGEN; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 12/12/2021

Event Type  malfunction  

Event Description

Covid isolation; took 3 quickvue antigen tests and all 3 showed a positive result.Then i got a pcr which told me i was negative.I also took a binaxnow rapid and that said negative.I proceeded to get 2 more pcrs and they were all negative.I have heard similar stories of false positives with quickvue with friends.Fda safety report id # (b)(4).

• Brand Name: QUICKVUE RAPID ANTIGEN
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 13110852
• MDR Text Key: 282977257
• Report Number: MW5106310
• Device Sequence Number: 3
• Product Code: QKP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/23/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other