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

Lot Number 21154001

Device Problems False Positive Result (1227); Defective Component (2292)

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

Event Date 09/05/2021

Event Type  malfunction  

Event Description

I got a false positive from an (b)(6) test.While they already have an unacceptably high rate of false positive (seriously, 37-75%? this shouldn't even be authorized, but whatever, that's up the fda), i believe my tests were also affected by some defect.But (b)(6) has stated that it wasn't affected by their voluntary recall.While i would love to get back the money their terrible tests cost me ((b)(6) on the tests themselves, then (b)(6) on laboratory tests to confirm the positive results were false), i don't expect to ever get back my money, time, or peace of mind.But the defects with (b)(6) are wider spread than their voluntary recall, so you should know that.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: 13110502
• MDR Text Key: 282977945
• Report Number: MW5106303
• 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: 12/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 21154001
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: FLONASE
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American