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

Lot Number (10)221CO20216

Device Problems Component Missing (2306); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 08/21/2022

Event Type  malfunction  

Event Description

Nothing happened when i took the test no bar of any kind because the vial that i had to add to the liquid was missing.All the test were missing the activating vial liquid.Home covid test provides by the government.

• Brand Name: IHEALTHY COVID-19
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS INC
• MDR Report Key: 15282533
• MDR Text Key: 298585626
• Report Number: MW5111656
• 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: 08/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: (10)221CO20216
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White