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

Model Number 20856362005894

Device Problems Component Missing (2306); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 04/15/2022

Event Type  malfunction  

Event Description

Ihealthlabs at home covid-19 antigen rapid test was defective and not working properly.Test kit package was supposed to contain 2 tests but only contained 1.The 1 test kit did not have sufficient fluid in the tube of extraction buffer to be usable.Test kit info: gtin(b)(4), lot no.(10): 211co21220, serial no.(b)(4).Use by(17):2022-06-19.Tube of extraction fluid lot no: cvd2121216 tube of extraction fluid use by: 2023-12-12.Unable to report directly to company due to security problems with the company's contact us web page.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 LABS, INC.; 120 san lucar ct.; sunnyvale, CA 94086
• MDR Report Key: 14160098
• MDR Text Key: 289754436
• Report Number: MW5109145
• 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: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/19/2022
• Device Model Number: 20856362005894
• Device Lot Number: 211CO21220
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White