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

Model Number ICO-3000

Device Problems Product Quality Problem (1506); Component Missing (2306); Inadequate Instructions for Non-Healthcare Professional (2956)

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

Event Date 06/14/2022

Event Type  malfunction  

Event Description

I tried using the government-supplied ihealth covid-19 test kit, model ico-3000.Was unable to use because instructions did not match contents of kit.Step 1 of the instructions clearly shows "1 empty tube" and "1 sealed solution" as two separate parts, for which the "sealed solution" is squeezed into the "empty tube".My kit contains neither - the "empty tube" has liquid in it, and there is no "sealed solution" container.I'm a retired registered pharmacist, and am fully aware of informational/instructional requirements of drugs and medical products.I'm shocked to think that a test kit with instructions that do not match the kit is being sent to people across the country.Granted, the fda version of the test kit instructions are accurate (include information that the tube and solution may come in two different versions), but that's available only through the fda site after substantial searching.But the fda site also includes the manufacturer instructions, which match the inaccurate instructions that come with the kit (https://www.Fda.Gov/media/153924/download).Who is reviewing this kind of thing? this may seem like a trivial matter to some, but in these days of such widespread mistrust of most anything the federal government has made public about covid, i would think that someone in fda would understand the negative potential of essentially asking users to disregard part of the instructions to complete the test.The way it stands, regardless of test result, there's going to be potential for doubt if a user has had to disregard part of the instructions.Also, i have to wonder if this is a result of the fda "emergency use" approval? should the public take that to mean that there are going to be significant omissions/inaccuracies or lack of thorough reviews before release? this certainly erodes my trust in using such a drug or device.Did not bother to complete the test (i.E., swab my nose) if i couldn't have any faith in the results.Fda safety report id# (b)(4).

• Brand Name: COVID-19 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS, INC.
• MDR Report Key: 14755829
• MDR Text Key: 294620269
• Report Number: MW5110385
• 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: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 07/29/2022
• Device Model Number: ICO-3000
• Device Lot Number: 221CO20130
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: IRBESARTAN ; METOPROLOL ; SERTRALINE; VITAMIN B12; VITAMIN D
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White