MAUDE Adverse Event Report: AI CURE LLC AICURE AIBREATHE; REMINDER, MEDICATION

Device Problem Inaccurate Information (4051)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 04/10/2019

Event Type  Injury  

Event Description

Hello, i am on a clinical trial for my sickness and they told me to use an app on my phone to tell me what pills to take and when.Now it's been months on this medicine and they told me that the app is telling me to take the wrong medications and i'm still feeling problems.The app is from aicure and it is telling me the wrong thing.Www.Aicure.Com.Fda safety report id# (b)(4).

• Brand Name: AICURE AIBREATHE
• Type of Device: REMINDER, MEDICATION
• Manufacturer (Section D): AI CURE LLC
• MDR Report Key: 8591404
• MDR Text Key: 144563657
• Report Number: MW5086461
• Device Sequence Number: 1
• Product Code: NXQ
• Combination Product (y/n): Y
• 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: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 86