MAUDE Adverse Event Report: TANDEM DIABETES CARE, INC. TSLIM X2; PUMP, INFUSION, INSULIN

Device Problems Device Displays Incorrect Message (2591); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 03/05/2022

Event Type  malfunction  

Event Description

Following a random cartridge error 20a, tandem tslim x2 insulin pump got stuck in an endless loop multiple times.Error started with a cartridge error 20a, which requires changing the cartridge.However, when clicking on "load" to change the cartridge, the error would immediately reoccur, preventing loading of a new cartridge.Only resetting the device (which requires a computer) would allow eventual loading.If this event occurred away from access to a computer, it would leave the user without insulin delivery, and unable to use the pump, which could quickly turn into a life-threatening condition.Additionally, after this occurred 3 times, tandem determined that the pump was defective and is replacing it with a new pump.Fda safety report id# (b)(4).

• Brand Name: TSLIM X2
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): TANDEM DIABETES CARE, INC.
• MDR Report Key: 13711102
• MDR Text Key: 287029957
• Report Number: MW5107962
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• 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: 03/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White