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

Lot Number 21193-436

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/30/2021

Event Type  malfunction  

Event Description

Ellume home kit covid test gave false positive result.I travelled to us on (b)(6).Authorities gave me an ellume covid self test package at (b)(6) airport and advised to do the test 3-5 days after travel.I did the test on (b)(6) 2021 at (b)(6), carefully following instructions.I was asymptomatic.The test result was that i was tested positive to covid 19.I managed to get pcr test on (b)(6) 2021 at (b)(6), and it was negative.I also tested myself on binaxnow self test 2 hours after ellume test, and binaxnow test was negative.I have been asymptomatic all the time.Product: ellume covid-19 home test lot number 21193-436 false positive result caused me cost of (b)(6) pcr test on (b)(6) and cost of binaxnow test.Additionally, it was a lot of work to get the pcr test scheduled, because all test places where crowded.Also it caused me a lot of worries concerning self quarantine, others that could have been exposed and worries about when i would be able to travel home and possibility of rescheduling flights home.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: 13205434
• MDR Text Key: 283762696
• Report Number: MW5106522
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/05/2022

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 Lot Number: 21193-436
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2022
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White