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

Lot Number F40704

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2022

Event Type  malfunction  

Event Description

Covid test quikvue.This test isn't very good.The arrow tip falls off and shows a pink line.Used two test.I called the maker and ask them about it.Said it happens sometimes but it's a negative.Although it looks positive.Fda safety report id # (b)(4).

• Brand Name: COVID AT HOME TEST QUICKVUE
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 13677696
• MDR Text Key: 286847687
• Report Number: MW5107890
• 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: 03/02/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/01/2023
• Device Lot Number: F40704
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2022
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White