MAUDE Adverse Event Report: IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem False Negative Result (1225)

Patient Problem Anxiety (2328)

Event Date 12/24/2021

Event Type  malfunction  

Event Description

I wanted to take a rapid covid test before going to a friend's for christmas eve dinner, and used a quickvue test.I waited until shortly before i planned on leaving, and carefully followed the instructions included in the box.The instructions stated that even a very faint pink line indicated a positive test result.Because of the poor design of the test, the pink line that would activate was faintly visible.Because it didn't seem quite right, i called my boyfriend who had taken the same brand of test the day before.He also reported seeing a faint pink line "if you squint," but that it was clear it hadn't "activated." in other words, we both had the experience of being able to see the line where it would appear/"activate" for a positive result.I followed up with a different test brand (ihealth).The ihealth test returned an unambiguous negative result, and i went to the small christmas eve gathering.However, and herein lies the problem, the quickvue results kept bothering me.After going to a christmas day movie and a small group dinner, i woke up at 5 a.M.Convinced that i had covid, and could be responsible for transmitting it to the people i spent christmas eve and christmas day with.I repeated an ihealth test and got negative results, which were confirmed later in the day with a curative pcr test.I understand that rapid antigen tests are in short supply, but i think the fda should take a closer look at the usability of the quickvue test and ask that the company make improvements.A false positive is certainly better than a false negative, but it causes anxiety.Via social media, i know of at least one other person who had a similar experience.Fda safety report id# (b)(4).

• Brand Name: IHEALTH COVID-19 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS, INC.; 120 san lucar ct.; sunnyvale CA 94086
• MDR Report Key: 13141571
• MDR Text Key: 283153903
• Report Number: MW5106392
• Device Sequence Number: 2
• 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: 12/29/2021
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2021
• Patient Sequence Number: 1
• Treatment: ADVIL ; ATENOLOL; ATORVASTATIN ; D-MANNOSE + CRANBERRY; DAILY VITAMIN ; NEXIUM (AT TIME OF TEST) ; ORAL CONTRACEPTIVES; VITAMIN D
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White