MAUDE Adverse Event Report: ANTIGEN SELF TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number	ICO-3000
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
We performed 2 separate tests using the ihealth mdel ico-3000 self test covid-19 antigen rapid test with the same person, one result was positive and the subsequent test was negative.The use of this product gives the user low confidence in the use of the test kit and its reliability.Fda safety report id # (b)(4).

• Brand Name: ANTIGEN SELF TEST
• Common Device Name: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 15079466
• Report Number: MW5111042
• Device Sequence Number: 11770952
• Product Code: QKP
• UDI-Device Identifier: 00856362005890
• UDI-Public: 856362005890
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/19/2022
• 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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/28/2022
• Device Model Number: ICO-3000
• Device Lot Number: 211CO21229-04
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2022
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White