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

Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
I used the ihealth covid-19 antigen rapid test kit, that i got free through the government, 5 times in total.The first time i used one, it worked fine.After that, the other 4 times, the small vial of liquid that had to be poured into the bigger vial did not have quite enough liquid to reach the first line.The instructions said that the liquid must reach the first line and not be higher than the second line, or the results of the test might be invalid.Due to the liquid not being enough to reach the line, i had to take the liquid from the second test that was in the box to fill the vial enough to make the tests valid.This of course made the second test in the kit unusable.Therefore, the government paid for two tests but only got one test that was usable.I think this was kind of a rip-off of the government.Reference report #mw5145585, #mw5145586, #mw5145587.

• Brand Name: IHEALTH COVID-19 ANTIGEN RAPID TEST
• Common Device Name: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
• Manufacturer (Section D): IHEALTH MANUFACTURING INC.
• MDR Report Key: 17743607
• Report Number: MW5145584
• Device Sequence Number: 5654479
• Product Code: QKP
• UDI-Device Identifier: 00856362005890
• UDI-Public: 856362005890
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/11/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/13/2022
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2023
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White