MAUDE Adverse Event Report: QUIDEL CORP. QUICKVUE OTC COVID 19 TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem False Positive Result (1227)

Patient Problem Emotional Changes (1831)

Event Date 09/22/2021

Event Type  malfunction  

Event Description

Our nephew took a quickvue covid test and received positive result.We saw him a few days earlier, so we also conducted the quickvue covid tests.Out of the test conducted on three family members, one came positive.We subsequently run a series of other tests and it turned out both our nephew's and our positive results were false.Before we've managed to figure it out, it caused a lot of commotion, stress, unnecessary quarantine, and cost a lot of money.Additionally, our nephew took both antigen and pcr test with healthcare provider and the whole family got tested, all with negative results.

• Brand Name: QUICKVUE OTC COVID 19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 12614865
• MDR Text Key: 276349785
• Report Number: MW5104489
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/07/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other