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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	09/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer experienced a blood glucose (bg) level of 425 mg/dl, with ketones a healthcare provided identified as life threatening.Cause was unknown.Customer went to the emergency room (er) and was admitted into the intensive care unit.Customer was treated with intravenous fluids of saline and insulin.Customer was released from the hospital on (b)(6) 2026 with the issue resolved and no permanent damage.Tandem technical support performed a full pump system check and verified that pump was operating appropriately and customer continued to use the pump for insulin therapy.
Additional Manufacturer Narrative
In use at the time of the event: cgm model: unknown.Mobile os: ios / ios_iphone 12 / unknown / ios 26.1.

• 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: 50945807
• Report Number: 3013756811-2026-177633
• Device Sequence Number: 16063957
• Product Code: QFG
• UDI-Device Identifier: 00850006613793
• UDI-Public: (01)00850006613793(11)220926
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/30/2026

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 Model Number: 1000354
• Device Catalogue Number: 1006408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2022
• 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: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 81 YR
• Patient Sex: Male