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

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 12/18/2022

Event Type  malfunction  

Event Description

Both test kits in an ihealth covid-19 antigen rapid test box had extremely faint control lines after 15 minutes elapsed (far fainter than usual, compared to 20+ tests i've done of this brand).

• Brand Name: IHEALTH COVID-19 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH MANUFACTURING INC.
• MDR Report Key: 16025600
• MDR Text Key: 306071245
• Report Number: MW5113883
• Device Sequence Number: 2
• Product Code: QKP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/18/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male