MAUDE Adverse Event Report: TANDEM DIABETES CARE, INC. T:CONNECT MOBILE APP FOR ANDROID; CONTINUOUS GLUCOSE MONITOR SECONDARY DISPLAY

Model Number	1.5
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
The product in question the tandem diabetes t:connect (b)(6) app - (b)(6) app for the t:slim x2 series of insulin pumps.The app is considered a medical device and has gone through fda approval.There are a few problems i believe bad enough to warrant removal of the app, the most dangerous of which has been present for over a year (based on app reviews and comments online).This isn't a compatibility or configuration issue - my phone is configured correctly and is "supported." the app randomly logs you out of your account, and requires you to log back in several times a day.There is no warning nor indication that anything is amis.As far as i can tell, the app ceases to function entirely when not logged in, meaning alerts will not sound.Obviously it also interrupts provider data upload.I have to log in at least twice a day, usually closer to four or five times.Tandem is aware and claims to be working on it.I believe the app's approval should be revoked and it removed from the play store until this is fixed.It purports to provide alerts you can trust that you cannot get from other apps (such as predicted future hypo events).The app does not remain running in the background despite all the correct system settings.When you close the foreground app, it is completely terminated.I checked the timers and it has zero background activity for the three weeks i've been using it.The persistent android notification does not launch the app when tapped, and the search keywords in the app manifest are incorrectly configured.Searching for "tandem" returns nothing, you must search for "t:connect" or "connect." this is a problem because time is critical in hypoglycemia and cognitive function is often impaired.People can remember "tandem" - "connect" makes no sense.It is not and should not be required to place the app on an already overfilled home screen; notifications should launch the app and it should be easier to search for.These are not inconveniences.These are safety issues, and tandem needs to fix them immediately, or pull the app.Fda safety report id# (b)(4).

• Brand Name: T:CONNECT MOBILE APP FOR ANDROID
• Common Device Name: CONTINUOUS GLUCOSE MONITOR SECONDARY DISPLAY
• Manufacturer (Section D): TANDEM DIABETES CARE, INC.
• MDR Report Key: 12583658
• Report Number: MW5104423
• Device Sequence Number: 14349039
• Product Code: PJT
• UDI-Device Identifier: 00850006613267
• UDI-Public: 00850006613267
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/02/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1.5
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2021
• Patient Sequence Number: 1
• Patient Weight: 161