MAUDE Adverse Event Report: IHEALTH MANUFACTURING INC. IHEALTH COVID 19 ANTIGEN TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number ICO-3000

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 09/15/2022

Event Type  malfunction  

Event Description

The control line on the test is very faint 15 minutes after taking the test.Lot number 213co21228-04.Use by date: 2022-06-27.Fda safety report id# (b)(4).

• Brand Name: IHEALTH COVID 19 ANTIGEN TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH MANUFACTURING INC.
• MDR Report Key: 15454764
• MDR Text Key: 300318038
• Report Number: MW5112116
• 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: 09/15/2022

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: 06/27/2022
• Device Model Number: ICO-3000
• Device Lot Number: 213CO21228-04
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2022
• Patient Sequence Number: 1
• Patient Sex: Female