MAUDE Adverse Event Report: TANDEM DIABETES CARE, INC. TANDEM T-SLIM SENSOR, GLUCOSE, INVASIVE

Device Problems Device Alarm System (1012); Premature Discharge of Battery (1057); Filling Problem (1233); Connection Problem (2900); Improper Flow or Infusion (2954); Activation Failure (3270)

Patient Problem Hyperglycemia (1905)

Event Date 10/01/2020

Event Type  Injury  

Event Description

I received a tandem insulin pump and a dexcom g6 cgm the "artificial pancreas.My cde and i set it up and the first month my blood sugars rarely went below 300 despite bolusing huge amounts of insulin.Proper control was only achieved with a syringe.I believe the issue is a flawed infusion set design discarded by minimed a long time ago.The injector implants the cannula but pulls the cannula out to a degree when needle is extracted.I was able to mitigate this using additional adhesive and trying to hold the set in place with my pinky.This did help but it currently is a rare thing to bolus 15 minutes out and stay under 200.An issue with delivery and absorption.There are additional flaws and irritants to this device including no visual check of reservoir levels.Several times i have bolused 15 units when pump indicates 90 units.When bolus is complete i am now in the red.Rarely have i had a sensor get to 10 days.Normally the sensor gives you multiple sensor error message prior to failure or patient exhaustion of hearing the "profanity" thing beep it's announcement of another error.Injectors fail to deploy and i had a transmitter die prematurely and it took dexcom nearly 2 weeks to provide a new one.There is now an fb page for g6 users.Lots of stories just like mine.Kind of hard to believe this garbage won the designation of artificial pancreas.Fda safety report id# (b)(4).

• Brand Name: TANDEM T-SLIM SENSOR, GLUCOSE, INVASIVE
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): TANDEM DIABETES CARE, INC.
• MDR Report Key: 11398397
• MDR Text Key: 234458231
• Report Number: MW5099704
• Device Sequence Number: 2
• Product Code: MDS
• 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: 02/25/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 118