MAUDE Adverse Event Report: IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST; COVID-19 TEST HOME COLLECTION KIT DEVICES

Device Problem False Positive Result (1227)

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

Event Date 08/31/2022

Event Type  malfunction  

Event Description

We tested both of our children on weds (b)(6) 2022 with the ihealth covid-19 antigen rapid test, one with an expiration date of 9/6/2022.Both tested positive, with a faint line.Both children were asymptomatic.We also tested our daughter with the cue systems naat on weds night and she was negative.We then re-tested them on thurs (b)(6) 2022 with the quickvue rapid antigen test, and they were both negative.We then did a pcr test on friday (b)(6) 2022, and they were both negative.We also tested them with an ihealth covid-19 antigen rapid test on friday (b)(6) 2022, with an expiration date in 2023, and they were negative.Thus, i would hypothesize that the shelf life of the ihealth tests is too aggressive, and the seemingly obvious false positives we experienced were related to the product being near its expiration date.Fda safety report id# (b)(4).

• Brand Name: IHEALTH COVID-19 ANTIGEN RAPID TEST
• Type of Device: COVID-19 TEST HOME COLLECTION KIT DEVICES
• Manufacturer (Section D): IHEALTH LABS, INC.; 150c charcot ave.; san jose CA
• MDR Report Key: 15379694
• MDR Text Key: 299592679
• Report Number: MW5111901
• Device Sequence Number: 1
• Product Code: QLW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/03/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/06/2022
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White