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	07/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In use at the time of the event: cgm model: g6.Mobile os: ios / ios_iphone 15 / 2.9.1 / ios_18.6.2.
Event or Problem Description
It was reported intermittently that the customer required several emergency room (er) visits to assistance and treat elevated blood glucose levels (value not provided).Reportedly, the customer experienced diabetic ketoacidosis.No additional information was provided.Multiple contact attempts were made by tandem technical support to obtain additional information regarding the event; however, no response was received from the customer.

• 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: 50331164
• Report Number: 3013756811-2026-150644
• Device Sequence Number: 5624752
• Product Code: QFG
• UDI-Device Identifier: 00389152000046
• UDI-Public: (01)00389152000046(22)1009640(11)231116
• 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): 08/19/2026

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: 1010007
• 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: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2023
• 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: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female