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	Mechanical Problem (1384)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A cartridge alarm was reported by the customer during the load process, with the blood glucose value displayed as "high," although the specific value was unknown.The customer managed the high blood glucose by administering a correction injection using a multiple daily injection method.The caller was educated to wait until prompted during the load process to remove the used cartridge, which they understood and acknowledged.Technical support resolved to replace the pump, even though it was out of warranty, but the customer declined the offer for an out-of-warranty loaner pump.

• 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: 24035874
• Report Number: 3013756811-2026-06294
• Device Sequence Number: 9074928
• Product Code: QFG
• UDI-Device Identifier: 00853052007325
• UDI-Public: 00853052007325
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/12/2026

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: 1000912
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2026
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2019
• 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: 21 YR
• Patient Sex: Female