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

Device Problems Product Quality Problem (1506); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 08/06/2022

Event Type  malfunction  

Event Description

I discovered today that the ellume covid-19 home test that my family paid (b)(6) for is entirely nonfunctional.I followed the steps exactly as detailed - unboxing components first and opening testing packages.There is no way to view the results of these home tests without using the app.The second step of the process is to download the android app, which i did, on my compatible recent model pixel phone.The android app freezes on the play video step, as detailed by many other users in the average 1.4 star google play store reviews going back at least as far as june.I tried many different ways to get it to advance without luck.I cannot use this opened test because it will be outside the one hour window listed, the app is non functional, and there's no other way to read the results.I didn't need a bluetooth connection - i literally just need to know if have transmissible covid.Since the test components are open and i cannot get the app to work within the hour, the test is spoiled.Also - a single use bluetooth device is an ecological disaster, and the decision making that went into all aspects of this product design is bananas.I have reached out to the company to complain, but i feel that this is a serious issue with an expensive and environmentally harmful product that can create major problems for consumers and should affect the status of their fda approval separate from the other false positive class action lawsuit.Fda safety report id# (b)(4).

• Brand Name: ELLUME COVID-19 HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ELLUME USA LLC.
• MDR Report Key: 15209906
• MDR Text Key: 297795578
• Report Number: MW5111406
• 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: 08/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Ethnicity: Non Hispanic