MAUDE Adverse Event Report: ELLUME LIMITED ELLUME COVID AT HOME TEST KITS; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 01/07/2022

Event Type  malfunction  

Event Description

Ellume at home covid test kits recalled - the problem is with the application for replacements.The process is overly time-consuming, difficult and untimely in so far as getting test kits replaced.Ellume 'apologizes' for the complicated process they require and blame it on fda requirements.I purchased 12 kits at over (b)(6) each and, after providing proof of purchase was told to complete the process of opening each test to obtain a number from each individual test kit.A process that took me four hours! it is a burden to ask consumers to go through a process that complicated and time-consuming in order to get replacements for expensive test kits that were defective and at no fault of the consumer.I have my doubts that the fda will require some type of proof from ellume for every single defective test they sold before they are allowed to replace it.If that is the requirement, it shouldn't be.In my opinion, ellume needs to get a slap on the wrist from the fda for the mess they caused.Fda safety report id#: (b)(4).

• Brand Name: ELLUME COVID AT HOME TEST KITS
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ELLUME LIMITED
• MDR Report Key: 13236194
• MDR Text Key: 283832433
• Report Number: MW5106580
• Device Sequence Number: 11
• 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: 01/07/2022
• 12 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White