MAUDE Adverse Event Report: ELLUME LIMITED ELLUME COVID19 TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Device (2588)

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

Event Date 09/11/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, in preparation for a visit to our son, my wife and i--both vaccinated--obtained covid pcr tests through our local hospital network.Both pcr tests were negative.The next day, we drove to (b)(6) and asked our son to purchase 2 rapid antigen tests that we would use on arrival.He purchased the ellume covid19 tests from (b)(6).My wife's test resulted in an error code #20 (insufficient quantity); my test was positive.I then purchased another test from the same (b)(6), and it was positive again.On (b)(6) 2021, my wife and i obtained pcr tests from same day health in their (b)(6).Both tests were negative.Fda safety report id# (b)(4).

• Brand Name: ELLUME COVID19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ELLUME LIMITED
• MDR Report Key: 12474586
• MDR Text Key: 271693690
• Report Number: MW5103918
• Device Sequence Number: 2
• Product Code: QKP
• 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: 09/13/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 71