MAUDE Adverse Event Report: IHEALTH LABS, INC. SELF AT HOME COVID 19 TEST KIT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number ICO-3000

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

I requested and received my ihealth home self test covid rapid antigen kit with 2 tests per box.I am a nurse.Someone did not do much quality assurance on this kit.If i had parkinson's or other dexterity problem i could not have used this kit.I received a kit requiring testing solution be deposited in the test tube.I wish i had received the prefilled tube kit.I had to "borrow" additional plastic vials of solution from the other kits 3 times before i could get enough solution squeezed out of the twist off vial into the test tube.It was full of sudsy bubbles or didn't open wide enough to get the needed solution in the tube.Whoever approved this kit didn't do their homework.It's awful.And i hate that it is made in china.I sure hope fda, cdc, or whoever is responsible for vetting test kits is doing all it can to get us manufacturers and a better job at quality control.Fda safety report id# (b)(4).

• Brand Name: SELF AT HOME COVID 19 TEST KIT
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS, INC.; 150c charcot ave; san jose CA 95131
• MDR Report Key: 14694938
• MDR Text Key: 294295963
• Report Number: MW5110302
• 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: 06/11/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/25/2024
• Device Model Number: ICO-3000
• Device Lot Number: CVD2230121
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2022
• Patient Sequence Number: 1
• Treatment: BUPROPION SR 150 MG DAILY; CENTRUM SILVER; CULTURELLE PROBIOTIC ; LISINOPRIL 10MG DAILY ; VIT D
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White