MAUDE Adverse Event Report: Tandem Diabetes Care t:slim X2 Insulin Pump with Control-IQ+ Technology; Alternate Controller Enabled Insulin Infusion Pump

Model Number	1002717
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that pump screen was dark and would not turn on despite multiple attempts to press button and connect to power, and pump showed red light and regular vibration indicating malfunction.There was no adverse impact to the customer¿s blood glucose level.Customer planned to use injections as backup insulin therapy, and technical support arranged replacement pump, provided instructions for putting malfunctioning pump into storage mode and returning it, and advised customer to set up pump settings and connect glucose sensor on replacement pump.
Additional Manufacturer Narrative
In use at the time of the event: cgm model: unknown.Mobile os: ios / ios_iphone xs / unknown / ios_18.6.2.

• 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 ; +1(858)224-6281
• MDR Report Key: 50946964
• Report Number: 3013756811-2026-177686
• Device Sequence Number: 9534283
• Product Code: QFG
• UDI-Device Identifier: 00389152407012
• UDI-Public: (01)00389152407012(22)1016546(11)250812
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K232380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 1002717
• Device Catalogue Number: 1014070
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2025
• 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
• Patient Age: 15 YR
• Patient Sex: Unknown