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

Model Number I-SRS-C-01

Device Problem False Positive Result (1227)

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

Event Date 12/25/2021

Event Type  malfunction  

Event Description

Used a ellume covid-19 home test after traveling and before visiting family members - with a positive result.Isolated myself and cancelled family visits for holidays.Requested additional testing, including abbott home test kit and laboratory rapid molecular naat tests.The positive result from ellume home test contradicts all of the other tests - including laboratory antigen tests taken 36h before (negative), abbott antigen home test done 24h after (negative) and rapid laboratory molecular naat test done 48h after (negative).Still no symptoms either.The ellume test used was not in the previous recall: lot number 21194-580.I have informed ellume, but will not use this product.It seems that their quality problems are not resolved and can lead to unnecessary concerns, lost work time, and extra testing if not addressed.I hope this message can help avoid this, if not an isolated incident and joined by other similar cases.Thank you, (b)(6).Fda safety report id# (b)(4).

• Brand Name: COVID-19 HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ELLUME LIMITED
• MDR Report Key: 13110672
• MDR Text Key: 282983391
• Report Number: MW5106307
• 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: 12/26/2021

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: Lay User/Patient
• Device Expiration Date: 09/30/2022
• Device Model Number: I-SRS-C-01
• Device Lot Number: 21194-580
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2021
• Patient Sequence Number: 1
• Treatment: ABBOTT COVID-19 BINAXNOW HOME TEST KIT
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White