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

Lot Number PL0F4-H

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 01/26/2022

Event Type  malfunction  

Event Description

I purchased several ellume covid 19 home test for home testing of possible covid.One of the tests did not work, did not provide results.I contacted the company, who said that they would send a replacement test.I have not received a replacement, nor have they responded to my follow up emails.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 / LIMITED
• MDR Report Key: 13479675
• MDR Text Key: 285454886
• Report Number: MW5107265
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: PL0F4-H
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic