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

Catalog Number I-SRS-C-01

Device Problems False Positive Result (1227); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2021

Event Type  malfunction  

Event Description

User reported false positive result.2x pcr negative.

Manufacturer Narrative

Report required by fda for eua.Investigation not complete at time of report.Follow-up report to follow completion of investigation.This is a retrospective report due to challenges implementing esg.

Event Description

User reported false positive result.2x pcr negative.

Manufacturer Narrative

Medical problem code changed to 1227.

• Brand Name: ELLUME COVID-19 HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ELLUME LIMITED; 57 didsbury st; east brisbane, qld 4169 ; AS 4169
• Manufacturer (Section G): ELLUME LIMITED; 57 didsbury st; east brisbane, qld 4169 ; AS 4169
• Manufacturer Contact: dakota scholefield ; 57 didsbury st; east brisbane, qld 4169 ; AS 4169
• MDR Report Key: 12921694
• MDR Text Key: 283519085
• Report Number: 3014862188-2021-00036
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA203011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: I-SRS-C-01
• Device Lot Number: 21131-004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 88801
• Patient Sequence Number: 1