MAUDE Adverse Event Report: TANDEM DIABETES CARE, INC. TANDEM TSLIM X2; AUTOMATED INSULIN DOSING , THRESHOLD SUSPEND

Model Number TSLIM X2

Device Problems Product Quality Problem (1506); Inaccurate Delivery (2339)

Patient Problem Insufficient Information (4580)

Event Date 07/02/2021

Event Type  malfunction  

Event Description

Improper medication display; the tandem tslim x2 has a 20 unit unusable amount of insulin that they do not clearly notate to the consumer.Further, they take this 20 units out of the total units in the pump and have another 10 unit amount that is considered ok in terms of calculating the +/- amount of total units.My cartridge alarm goes off at 20 units.I attempt to get it changed then but sometimes i don't.On (b)(6) 2021 i decided to determine how much insulin was left in the cartridge because the number the total units were not calculating correctly to what was put into the cartridge lately.I pulled 50 units out, which i had to discard.The next cartridge i used had almost 40 units left at change out which was also discarded.Since we cannot use the generic insulin in our insulin pumps.This is costly.That is a total of 50 units of insulin i could have used between the two cartridges.I understand the pump cannot push out all the insulin but people who use the insulin pumps cannot afford to lose 30 units of insulin each time they change a cartridge.Novolog and humalog are not cheap even if you are on commercial insurance, plus insulin pump supplies must be purchased.Not to mention for those who are lucky enough to where the glucose sensor and transmitter, those supplies must be purchased.Type 1 diabetes is one of the most costly diseases between insurance and the consumer, we do not need this.It is my recommendation that tandem start by explaining that the last 20 units are not viable and add it to all consumer documentation where appropriate, make the count accurate, stop insulin delivery at 20 units period, and have the user change out the pump.All of these items are easily fixed either in the software air provided documentation.Plus, it assists the user in truly understanding this insulin pump's capability.Fda safety report id # (b)(4).

• Brand Name: TANDEM TSLIM X2
• Type of Device: AUTOMATED INSULIN DOSING , THRESHOLD SUSPEND
• Manufacturer (Section D): TANDEM DIABETES CARE, INC.
• MDR Report Key: 12195861
• MDR Text Key: 262642744
• Report Number: MW5102621
• Device Sequence Number: 1
• Product Code: OZO
• 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: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TSLIM X2
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 95