MAUDE Adverse Event Report: IHEALTH LABS, INC. COVID-19 ANTIGEN RAPID TEST - SELF-TEST AT HOME RESULITS IN 15 MINUTES; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number	ICO-3000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Ihealth rapid covid-19 at home kit.Received boxes from trusted provider (county library).One box (two tests) provided "inconclusive" results, tests done 4 hours apart; repeated test with different box, different lot # (negative results), subsequent days.When test was repeated with boxes from different lot numbers, all others were negative.Fda safety report id # (b)(4).

• Brand Name: COVID-19 ANTIGEN RAPID TEST - SELF-TEST AT HOME RESULITS IN 15 MINUTES
• Common Device Name: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS, INC.; 150c charcot ave; san jose CA 95131
• MDR Report Key: 15265426
• Report Number: MW5111606
• Device Sequence Number: 5566746
• Product Code: QKP
• UDI-Device Identifier: 00856362005890
• UDI-Public: 856362005890
• Combination Product (Y/N): N
• 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): 08/17/2022
• 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
• Device Expiration Date: 06/27/2022
• Device Model Number: ICO-3000
• Device Catalogue Number: GTIN (01) 20856362005894
• Device Lot Number: (10) 213CO21228-04
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2022
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Female