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

Model Number ICO-3000

Device Problems Use of Device Problem (1670); Inadequate Instructions for Non-Healthcare Professional (2956); Inadequate User Interface (2958)

Patient Problem Insufficient Information (4580)

Event Date 01/07/2022

Event Type  malfunction  

Event Description

Ihealth covid test kit (https://www.Fda.Gov/media/153925/download) approved by fda under emergency use, does not contain the instruction on how to use it, nor which result means positive and which means negative.Instead, it needs the user to scan an qr code for a mobile app for the instruction only available for later ios or newer android.I personally use (b)(6), so i cannot have the digital user instruction.And it is not available online through their website, ihealth always directs the need to the mobile app.I had to ask a friend of mine who is located in the (b)(6) about how to understand the result from the test kit (one bar, two bars) because he has been using rapid at home test kit frequently.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.
• MDR Report Key: 13236246
• MDR Text Key: 283832487
• Report Number: MW5106582
• 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: 01/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ICO-3000
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic