MAUDE Adverse Event Report: QUICKVUE HOME COVID TEST KIT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problems False Negative Result (1225); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Reporter called to report a product issue with the quickvue at home covid test.Patient stated she is a nurse and performed two of these tests the other day on her grandkids and says they were defective.Reporter stated the tests provided false negative results, and feels this device issue is extremely urgent and needs immediate attention from fda.Reporter stated that along the window of the testing strip it looked a little bit pink at the test line, but was very faint.She said she put her finger on the overlay of the strip and a positive pink line was being obscured by the configuration of the testing strip.Reporter said when she pulled the overlay away there was a very positive pink line.Reporter said she basically dissected the strip and found the pink positive line very obviously there, and she said her grandkids were showing symptoms.

• Brand Name: QUICKVUE HOME COVID TEST KIT
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 13344458
• MDR Text Key: 284510821
• Report Number: MW5106953
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/24/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female