MAUDE Adverse Event Report: ELLUME LIMITED ELLUME COVID 19 HOME TEST KIT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 21194-722

Device Problems Display or Visual Feedback Problem (1184); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 12/11/2021

Event Type  malfunction  

Event Description

New type test error; ellume covid-19 home test kit failed to reach a result and instead displayed an error 29 message and statement to call the company.Intended for use on (b)(6) female that was exposed to covid-19 active carrier during school.I thereafter purchased a binoxnow test kit and the female tested positive, confirmed by hospital pcr test.Luckily, i had the money to buy another kit since waiting was not an option given her symptoms - ellume had no answer and store would not make a refund.After contacting ellume, the company wants to send a replacement kit (what good is that) and would not tell us what an "error 29" message means.The fda should not conditionally or otherwise approve a product with a known failure rate.Ellume confirmed this was not a recalled product such as happened earlier this year for false results.This test kit simply did not work.I feel sorry for poor folks who might only be able to buy one with means to buy a replacement while they wait for ellume to make good on their defective product.Fda safety report id# (b)(4).

• Brand Name: ELLUME COVID 19 HOME TEST KIT
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ELLUME LIMITED
• MDR Report Key: 13018679
• MDR Text Key: 282421053
• Report Number: MW5106072
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 21194-722
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 12 YR
• Patient Sex: Female
• Patient Weight: 44 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American