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

Device Problems False Positive Result (1227); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 10/02/2021

Event Type  malfunction  

Event Description

Ellume covid-19 home test - i had false positive results on three tests and technical error on one further test.The ellume "analyser id" number for the three ellume false positive tests is (b)(4), and for the technical error test is (b)(4).These ellume tests were taken over the period from (b)(6) 2021 to (b)(6) 2021.Ellume states that none of these tests are from lot numbers included in ellume's current voluntary recall.In each case i had a second test performed by an independent laboratory within 24 hours of the incorrect ellume test result.In all cases the second test showed a negative result.The second tests were pcr tests and, in addition, i had two antigen tests performed shortly after the last ellume test (one a binaxnow antigen home test and one an antigen test performed by an independent laboratory) and both of these antigen tests also showed a negative result.I can provide you copies of all the tests performed by independent laboratories if you wish to see them.Based on the forgoing, it appears ellume's false positives problem extends beyond the lot numbers included in ellume's current voluntary recall.Fda safety report id # (b)(4).

Event Description

Additional information received from reporter for report mw5104574 on 12/7/2021.Please ref access number mw5104574.Ellume eventually included these tests in its broadened voluntary recall and sent me five replacements.Ellume covid-19 home tests with lot number pjoan-h.I used one of these yesterday, (b)(6) 2021, and received another false positive, confirmed by a negative pcr test done by an independent lab within 24 hrs.I have not used the other four replacement tests.I will send them to you if you request them within 48 hrs, otherwise i plan to throw them out.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: 12632412
• MDR Text Key: 276664764
• Report Number: MW5104574
• Device Sequence Number: 2
• 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,Followup
• Report Date: 10/08/2021
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/07/2021
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White