MAUDE Adverse Event Report: DEXCOM, INC. THE CLARITY APPLICATION; CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE

Device Problems Failure to Transmit Record (1521); Application Program Problem (2880)

Patient Problem Insufficient Information (4580)

Event Date 09/06/2021

Event Type  Injury  

Event Description

I use the dexcom g6 sensor and transmitter.I use my (b)(6) to collect data and tell me my blood glucose levels.I use the clarity app and dexcom g6 app.I inserted a new transmitter on (b)(6) 2021.I have not had a previous problem with the applications or sharing the data.On "(b)(6)" i tried to transmit data from my clarity application (for the last 90 days) to my physician to make medical decisions on insulin dosages.The clarity app failed to record data for over 3 months and i was not aware.I could see my blood glucose readings 24 hours a day on the dexcom app so i didn't realize the clarity application wasn't saving them.I was unable to give a history to my physician.She had to make decisions regarding insulin dosages based on my omnipod data and blood glucose levels i had manually entered there.I wear my dexcom g6 24 hours a day.I called dexcom twice to try to resolve the problem.This included deleting and reinstalling the applications.The company states the transmitter is supposed to record data and even if there is a glitch in the software, it should have picked up the data from the time my last transmitter was inserted ((b)(6) 2021).However, on (b)(6) 2021 it only shows data from 8pm last night until today and blood glucose levels before (b)(6) 2021.I was finally told that if the phone updates automatically, it can affect the functioning of the clarity application.I was then told: 1-check clarity application at least weekly 2- turn off automatic updates on my phone 3- need to keep using dexcom receiver if use phone.( but said they really only wanted me to use my phone) i expressed concern that patients are given basic safety information: check clarity app weekly to be sure functioning; warn that (b)(6) phone updates can affect the clarity application; encourage patients to carry the dexcom receiver as well as their phone for back-up.I suggested this could be fixed easily by providing patients information about the basic concerns with the clarity application.I was told they could not do this and it basically was not their responsibility.I spoke with a representative named (b)(6) at dexcom.Fda safety report id# (b)(4).

• Brand Name: THE CLARITY APPLICATION
• Type of Device: CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12615790
• MDR Text Key: 276477829
• Report Number: MW5104525
• Device Sequence Number: 2
• Product Code: PHV
• 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: 10/06/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 102