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

Lot Number 213C021228

Device Problem Product Quality Problem (1506)

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

Event Date 08/15/2022

Event Type  malfunction  

Event Description

I used two boxes (3 tests) of the ihealth covid-19 antigen rapid test.None of the tests showed control lines, indicating the test did not work.Not sure if this is indicative of the expiration date "not" being consistent with 6 month extension.The expiration date on the box is 22-06-2027, but that was extended 6 months by fda.The lot number is 213c021228.Fda safety report id# (b)(4).

• Brand Name: IHEALTH COVID-19 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH; 120 san lucar ct.; sunnyvale CA 94086
• MDR Report Key: 15249274
• MDR Text Key: 298248669
• Report Number: MW5111543
• Device Sequence Number: 2
• 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: 08/15/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/27/2022
• Device Lot Number: 213C021228
• Patient Sequence Number: 1