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

Model Number ICO-3000

Device Problems Labelling, Instructions for Use or Training Problem (1318); Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 05/28/2022

Event Type  malfunction  

Event Description

I was using an ihealth covid-19 antigen rapid test at home.The instructions for use did not match the materials i received in the test.The buffer that was supposed to be in the sample vial was packaged separately and the instructions to dispense the separate buffer were not in the instructions for use.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: 14592286
• MDR Text Key: 293341595
• Report Number: MW5110062
• 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: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/19/2022
• Device Model Number: ICO-3000
• Device Lot Number: (10): 222CO20120
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose