MAUDE Adverse Event Report: IHEALTH LABS, INC. / IHEALTH MANUFACTURING 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 Insufficient Information (4580)

Event Date 02/13/2023

Event Type  malfunction  

Event Description

Problem: 2 out of 3 tests from the same lot showed very weak control (c) lines, and no visible test (t) lines.Is this a valid negative test? when my test was read at 15 minutes, the _control_ line was very faint.I retested using another kit from the same lot which also resulted in a very faint control line.Another individual used a third test from the same lot which had a normal dark control line.I followed the test kit instructions accurately to the best of my knowledge.I had used the same brand of test kit previously, and this was the first time i had this issue.Lot#: 221co20217, exp: printed 2022-08-16; fda extended to 05/16/2023 (https://www.Fda.Gov/media/164551/download).

• Brand Name: IHEALTH COVID-19 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS, INC. / IHEALTH MANUFACTURING INC.
• MDR Report Key: 16397947
• MDR Text Key: 309888304
• Report Number: MW5114998
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/14/2023
• 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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2023
• Patient Sequence Number: 1