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

Lot Number 221CO20120

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2022

Event Type  malfunction  

Event Description

Ihealth covid test lot #221co20120.No control line (3 cartridges all failed, different brand test worked fine, not user error).

• Brand Name: COVID-19 RAPID ANTIGEN TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH MANUFACTURING INC.
• MDR Report Key: 16067467
• MDR Text Key: 306337689
• Report Number: MW5114038
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/23/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/18/2022
• Device Lot Number: 221CO20120
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1