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

Lot Number CVD2131015

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 01/18/2022

Event Type  malfunction  

Event Description

I attempted to take a test with a store-bought ihealth covid-19 antigen rapid test, made by ihealth labs, inc.This test kit requires the user to capture a nasal swab sample, mix it with an liquid solution (which is in a small plastic tube), and then add the sample to the test card.Upon going to mix my nasal swab with the liquid solution, i noticed that there was no liquid in the tube.Absolutely none.There was nothing to mix my swab with.Therefore, i had to discard the test.The test kit (outer cardboard box) is labeled gtin(01): 20856362005894, lot no.(10): 211c)21105.The plastic tube is labeled cvd2131015.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.
• MDR Report Key: 13333666
• MDR Text Key: 284455063
• Report Number: MW5106878
• Device Sequence Number: 1
• 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: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/29/2023
• Device Lot Number: CVD2131015
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Hispanic
• Patient Race: White