MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY; ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP

Model Number	1000096
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported a cartridge change error with their insulin pump.There was no adverse impact to the customer's blood glucose level as it did not exceed critical levels.Initially, the customer was guided by technical support to inspect various parts of the pump and attempt to load a new cartridge; however, this did not resolve the issue.Following these efforts, a callback was arranged by the customer support team, where the customer expressed continued difficulties with the same error and a recent low blood glucose episode of 72 mg/dl.Despite attempts to resolve the error, the issue persisted, leading to the decision to replace the pump.Although the pump was out of warranty, the customer declined the option for an out-of-warranty loaner pump and opted to use multiple daily injections (mdi) to avoid interruptions in insulin delivery.The ongoing issue had been reported previously under different cases.

• Brand Name: T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
• Common Device Name: ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP
• Manufacturer (Section D): TANDEM DIABETES CARE; 12400 high bluff drive; san diego CA 92130
• Manufacturer Contact: john connell ; 12400 high bluff drive; san diego, CA 92130 ; 858 224-6281
• MDR Report Key: 24377400
• Report Number: 3013756811-2026-31149
• Device Sequence Number: 11971209
• Product Code: QFG
• UDI-Device Identifier: 00853052007257
• UDI-Public: 853052007257
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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: 1000096
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TANDEM - CARTRIDGE
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 48 KG