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

Lot Number 222CO20212

Device Problem Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 04/02/2022

Event Type  malfunction  

Event Description

In-home covid-19 test has the wrong instructions.Package contains unfilled sample collection tubes but the instructions are for prefilled tubes.It took a bit to figure out why the directions didn't match the supplies, i figured it out but many won't and will either waste the test or do it incorrectly and may get incorrect result.Ihealth covid-19 antigen rapid test see photo for lot number etc.Fda safety report id# (b)(4).

Event Description

Additional information received for report mw5108767 on: 04/14/2022, procode qkp.

• Brand Name: IHEALTH COVID-19 ANTIGEN RAPID TEST KIT
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS, INC.
• MDR Report Key: 14021248
• MDR Text Key: 288787567
• Report Number: MW5108767
• 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,Followup
• Report Date: 04/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/11/2022
• Device Lot Number: 222CO20212
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2022
• Patient Sequence Number: 1