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

Lot Number 21193-441

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 12/28/2021

Event Type  malfunction  

Event Description

Ellume home test kit was used and the result was positive for covid.Patient tested again with another ellume test kit.Second kit tested positive as well.Patient was then binax now antigen tested and rapid pcr tested; both were negative for covid.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; east brisbane ; AS
• MDR Report Key: 13141596
• MDR Text Key: 283153993
• Report Number: MW5106393
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/29/2021

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: Health Professional
• Device Expiration Date: 09/30/2022
• Device Lot Number: 21193-441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White