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

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 04/16/2023

Event Type  malfunction  

Event Description

I've had multiple defective covid-19 tests from the ihealth labs, inc.I followed the instructions exactly as written and reread them multiple times but both tests in the box did not show a control "c" line on the card after placing 3 drops of the solution.I looked very carefully and there wasn't even a faint line.I've included the detailed information for this box of 2 covid tests but this has happened to me before a couple of months ago with another box of 2 from ihealth where the first test worked ok and i could see the "c" control line on the test card but the second test was defective and didn't show any line.In addition i took a test from ihealth labs, inc.Last week that did not contain enough test solution to be able to complete both tests.They make two versions of this test.One has the solution already in the vial, and the second contains the solution in a separate dropperette that must be opened and put into the vial.The instructions state that the liquid needs to be "level with or above edge 2" and to "please do not proceed with this test, if the liquid level is below edge 2, as this may result in false or invalid results." there was not enough liquid solution to fill to edge 2 for either of the tests in the box.I didn't save the lot numbers from the box but i do know that it was a test that was expired but had that date extended by the fda according to information on the fda website.Reference report: mw5116771.

• Brand Name: COVID-19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS, INC. / IHEALTH MANUFACTURING INC.
• MDR Report Key: 16768566
• MDR Text Key: 313642697
• Report Number: MW5116772
• 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: 04/16/2023

1 Device was Involved in the Event

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: 08/14/2022
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2023
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White