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	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that intermittent occlusion alarms occurred, leading to the customer experiencing intermittent high blood glucose (bg) levels.The customer¿s bg level was displayed as ¿high¿; however, a specific value was not provided.The elevated bg was addressed by a correction bolus via the pump without requiring third-party assistance.Customer changed infusion set and cartridge to resolve the issue.Reportedly, the customer had been using the same cartridge for over 3 days using novolog insulin.Tandem customer technical support informed customer that novolog insulin is indicated for use with tandem supplies for 3 days.Caller understood and acknowledged.Ultimately the customer reverted to a back up pump for insulin therapy.

• 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: 24743006
• Report Number: 3013756811-2026-58640
• Device Sequence Number: 9060646
• Product Code: QFG
• UDI-Device Identifier: 00389152319810
• UDI-Public: (01)00389152319810(22)1012742(11)240717
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K232380
• 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOVOLOG / NOVORAPID - INSULIN.; TANDEM - CARTRIDGE.; UNOMEDICAL - INFUSION SET.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Male