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	Pumping Stopped (1503)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A malfunction on the pump was reported by the caller, with no notable events occurring prior to the issue.Customer¿s blood glucose (bg) level was displayed as "high"; however, specific value was not provided.To address this, the customer administered a correction injection via multiple daily injections (mdi) and did not require assistance from a third party.Technical support provided the customer with instructions to reset the pump, which successfully addressed the malfunction, as it did not recur.The customer was advised to continue using the pump and was informed to contact technical support if the malfunction code appeared again.

• 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 ; 858 224-62
• MDR Report Key: 24741918
• Report Number: 3013756811-2026-58542
• Device Sequence Number: 8995229
• Product Code: QFG
• UDI-Device Identifier: 00389152319810
• UDI-Public: (01)00389152319810(22)1012742(11)250209
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K203234
• 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): 03/31/2026

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: 1013198
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2025
• 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: Other
• Patient Age: 42 YR
• Patient Sex: Female