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

Device Problems Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/24/2022

Event Type  malfunction  

Event Description

Multiple problems with ihealth covid-19 antigen rapid test kits--today's testing is an example.Both of 2 kits in one box in lot no.(10):222c020210 were faulty, unusable, due to an extremely faint positive control.This is about the 8th of these tests that i have found to be faulty due to incorrect control, not all in the same lot (expiries july to aug 22), not always both kits in same box of 2, and also in one box of 2 kits, only 1 kit was present (an extra copy of instructions had been inserted instead).This is not user error: i am a medical professional, and the fluid volume in the tube was correct (some kits have prefilled tubes, some must be filled by user--both have had incorrect controls), the drops used were correct and correctly administered on the kit and fluid diffused correctly to the end of the window (you can see it as a slight color change rolling across the test window).The kits have been within their extended expiry.Very poor quality control by manufacturer.No one was harmed, because testing was repeated, but to have to test 3 times in rapid succession to obtain a valid result is not acceptable, and of course the unusable kits were purchased (in this case, by federal government -- were part of mailed out kits -- or by local government, which distributes them in libraries).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.
• MDR Report Key: 15673241
• MDR Text Key: 302494249
• Report Number: MW5112835
• Device Sequence Number: 2
• 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: 10/24/2022
• 8 Devices were Involved in the Event: 1 2 3 4 5 6 7 8

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1