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

Device Problems Nonstandard Device (1420); Device Markings/Labelling Problem (2911); Missing Test Results (3267)

Patient Problem Insufficient Information (4580)

Event Date 12/26/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022 gentlemen and ladies: based on the announcements that covid tests could be obtained at the pharmacies, my wife got 4 "free" boxes from the local (b)(6) pharmacy, i was at home with my grandson; we had both tested positive several days earlier on "binax" tests that we already had.When my wife questioned the fact that the four boxes were past the 2022-07-20 expiration date, the pharmacy tech said that the dates had been extended, and to check on line at the fda website.So i did this, and for our boxes of ihealth tests lot 223co20121 and original expiration of 2022-07-20 the new expiration was shown as 2023-01-20.This was on (b)(6) 2022.So we used the tests from one box for myself and my grandson on (b)(6) 2022.After 20 minutes, neither test showed any visible lines, for either the control line or the test line, result = not valid.So we tried again with another box of two tests: again after 15 minutes there were no lines, and nothing at 20, 25, 30 minutes except the very faintest of lines in the test area, nothing at all in the control blocks.Again: result = not valid.Then my daughter brought over another box of the binax tests, and when we tried with these two tests, both indicated very distinct lines on both control and test areas.We were both clearly still positive.The expiration date on the binax box was 2023-09-27.Obviously either the ihealth rapid at home tests in the orange box don't work, or the "extended" expiration dates are not valid.I suspect it is the latter.Please review and correct your information.Thank you for your time and attention to this matter.(b)(6).Ihealth boxes lot and orig date and revised date data: 223co20121, 2022-07-20, 2023-01- 20.

• Brand Name: IHEALTH COVID-19 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH MANUFACTURING INC.
• MDR Report Key: 16103055
• MDR Text Key: 306799146
• Report Number: MW5114160
• 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: 12/31/2022
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2023
• Patient Sequence Number: 1
• Treatment: HYDROCHLOROTHIAZIDE; INSULIN ; LUTEIN; VITAMIN C
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White