MAUDE Adverse Event Report: IHEALTH LABS, INC. IHEALTH COVID19 RAPID ANTIGEN TEST KIT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 221CO20220

Device Problems Product Quality Problem (1506); Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/29/2022

Event Type  malfunction  

Event Description

The ihealth rapid antigen test i attempted to use did not contain enough pre-filled liquid to conduct the test accurately.This has happened to me two separate times in two separate boxes of test kits.The manufacturer states that the liquid must reach a specific level on the tube in order to perform a valid test.Therefore, the test is invalid and useless.I wrote to the company today.I feel that the fda needs to examine this.Fda safety report id # (b)(4).

• Brand Name: IHEALTH COVID19 RAPID ANTIGEN TEST KIT
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS, INC.; 150c charcot ave; san jose CA 95131
• MDR Report Key: 14574482
• MDR Text Key: 293281568
• Report Number: MW5110019
• 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: 05/29/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/19/2022
• Device Lot Number: 221CO20220
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: IMITREX FOR MIGRAINE HEADACHES AS NEEDED
• Patient Age: 11 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Hispanic
• Patient Race: White