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

Model Number ICO-3000

Device Problem Defective Component (2292)

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

Event Date 07/26/2022

Event Type  malfunction  

Event Description

My son is experiencing a few symptoms (low fever, congestion, headache) so i opened one of the ihealth self-tests covid-19 antigen rapid tests (model ico-3000).I ended up having to use both tests in the box because the first test revealed no lines (no t line, no c line) even after 15 minutes.For the second test, the c line was very faint (still no t line).This same thing happened yesterday ((b)(6) 2022) when i tested my other son (same symptoms) - one of the tests in that box revealed no lines and the second test had a very faint c line.So in the 2 of the 4 boxes i received, 2 of the 4 tests were defective.This does not make me feel very confident in the results i received.I feel i should receive new boxes to replace the tests that were defective.The following information is from today's box: gtin(01): (b)(4), lot no.(10): 221co200221, use by(17): 2022-08-20.Thank you, rima mason.There were no test results.That's the problem.Fda safety report id# (b)(4).

• Brand Name: IHEALTH COVID-19 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS, INC.; 150c charcot ave.; san jose CA 95131
• MDR Report Key: 15129661
• MDR Text Key: 296988661
• Report Number: MW5111164
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00856362005890
• UDI-Public: 856362005890
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 07/26/2022
• 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: Other
• Device Expiration Date: 08/20/2022
• Device Model Number: ICO-3000
• Device Catalogue Number: GTIN(01): 20856362005894
• Device Lot Number: 10): 221CO20221
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2022
• Patient Sequence Number: 1
• Treatment: EPINEPHRINE AUTO-INJECTOR FOR USE AS NEEDED DUE TO ALLERGIES
• Patient Age: 12 YR
• Patient Sex: Male
• Patient Weight: 41 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White