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

Model Number	1000354
Medical Device Problem Codes	Incorrect Measurement (1383); Pumping Stopped (1503)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pump's screen unexpectedly went blank and the led was not blinking.The customer¿s blood glucose (bg) level was displayed as ¿high¿; however, a specific value was not provided.The customer addressed the high blood glucose by administering a bolus via the pump without requiring assistance from a third party.Technical support explained that the shutdown was due to a fuel gauge fluctuation issue and instructed the customer on resetting procedures for the pump.Furthermore, the customer was informed that this issue has been resolved in a software update, and they acknowledged the information provided.

• 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: michael trier ; 12400 high bluff drive; san diego, CA 92130 ; 858 401-1451
• MDR Report Key: 24117755
• Report Number: 3013756811-2026-11127
• Device Sequence Number: 9515672
• Product Code: QFG
• UDI-Device Identifier: 00853052007318
• UDI-Public: (01)00853052007318
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 01/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1000354
• Device Catalogue Number: 1000911
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2026
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Female