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

Device Problem Product Quality Problem (1506)

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

Event Date 07/29/2022

Event Type  malfunction  

Event Description

I want to register a complaint about the covid home tests i was sent.This seems to be the only forum because your phone system stinks.The covid home tests are useless to anyone who doesn't have a smartphone.Why would you presume to use tests that require a connection via cell phone to an app when there are tests available that are easy and don't require a connection? i was told by the customer service dept of the company that produced the tests i received to donate them and apparently, there are no other options.Again, this is a terrible way to do business.

• Brand Name: ELLUME COVID-19 HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ELLUME USA LLC.
• MDR Report Key: 15147373
• MDR Text Key: 297142124
• Report Number: MW5111206
• 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: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Race: White