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

Lot Number PE02P-H

Device Problems Nonstandard Device (1420); Use of Device Problem (1670); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 11/12/2021

Event Type  malfunction  

Event Description

The test kit will not connect to the phone and is completely useless because of the recall.Fda safety report id# (b)(4).

• Brand Name: ELLUME HOME COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ELLUME LIMITED
• MDR Report Key: 12828262
• MDR Text Key: 280950451
• Report Number: MW5105362
• 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: 11/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Lot Number: PE02P-H
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White