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

Model Number ICO-3000

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 04/25/2023

Event Type  malfunction  

Event Description

Have opened five ihealth covid19 antigen rapid tests (provided courtesy of us government), have very carefully put liquid into vial "it is acceptable that the liquid level is above edge 2.However, do not proceed with the test, if the liquid level is below edge 2, as this may result in false or invalid results".All five tests so far have had liquid provided level below edge two.Model ico-3000, lot no(10)222co20212 (4 boxes).Extended expiration date from 2022-08-11.Reference report #mw5117201, #mw5117202, #mw5117203, #mw5117204.

• Brand Name: IHEALTH COID-19 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH MANUFACTURING INC.
• MDR Report Key: 16854931
• MDR Text Key: 314469592
• Report Number: MW5117205
• Device Sequence Number: 1
• 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: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/08/2023
• Device Model Number: ICO-3000
• Device Catalogue Number: GTIN901)20856362005894
• Device Lot Number: (10) 222CO20212
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ASPIRIN 81MG; LISINOPRIL ; SIMVASTATIN
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White