MAUDE Adverse Event Report: ELLUME USA LLC. ELLUME COVID-19 HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number QA00D-H

Device Problems Product Quality Problem (1506); Application Program Problem (2880)

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

Event Date 07/26/2022

Event Type  malfunction  

Event Description

Product is ellume covid-19 home test.The test requires that the user download and use a (free) proprietary app on their phone.The app can be downloaded however it didn't work on my google phone.The app walks you through several steps then always gets stuck at the same stop, where you need to watch a video.The video doesn't play, and there is no way to skip to another step.There is no way to watch the video other than supposedly using their broken app, and there is no way to do the test without watching the video to which there is no access.This product needs to be removed from shelves until it is fixed.Home covid test.

• Brand Name: ELLUME COVID-19 HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ELLUME USA LLC.
• MDR Report Key: 15183136
• MDR Text Key: 297500407
• Report Number: MW5111296
• 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

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 Lot Number: QA00D-H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2022
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White