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

Model Number I-SRS-C-01

Device Problems Therapeutic or Diagnostic Output Failure (3023); Wireless Communication Problem (3283)

Patient Problem Viral Infection (2248)

Event Date 01/10/2023

Event Type  malfunction  

Event Description

Piece of "profanity" ellume test requires blue tooth connectivity and would not connect, my blue tooth speakers connect and work fine, clearly the problem is not my phone.The test won't even give you any result without blue tooth, pisses me off, went and got regular reliable paper strip covid test.Which worked fine.Ellume is clearly run by a bunch of idiots.Build redundancy into products so they will work with or without bluetooth.

• Brand Name: COVID 19 HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ELLUME LIMITED
• MDR Report Key: 16157171
• MDR Text Key: 307499315
• Report Number: MW5114303
• 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: Unknown
• Type of Report: Initial
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Model Number: I-SRS-C-01
• Device Lot Number: QC06E-H
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2023
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White