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

Catalog Number	1014072
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperglycemia (1905); Myocardial Infarction (1969); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	08/09/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that a customer had passed away on (b)(6) 2026.Their cause of death was reported as diabetic ketoacidosis which led to heart attack, and 40% blood flow.Healthcare provider noted that patient was out of remission from cancer and refused all treatment for all issues.The customer was wearing the pump at the time of death.A review of pump data will be performed, and the results will be submitted in a supplemental report.
Additional Manufacturer Narrative
In use at the time of the event: cgm model: unknown.Mobile os: unknown.

• 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: 50734126
• Report Number: 3013756811-2026-165363
• Device Sequence Number: 16110350
• Product Code: QFG
• UDI-Device Identifier: 00389152407210
• UDI-Public: (01)00389152407210(22)1017689(11)251027
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K250792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 1014072
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2025
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 69 YR
• Patient Sex: Unknown
• Patient Weight: 150 LB