MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY; ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP

Catalog Number	1017064
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an occlusion alarm occurred.The customer¿s blood glucose (bg) level was displayed as ¿high¿; however, a specific value was not provided.A manual insulin injection was administered to address bg level.Reportedly, the customer was using fiasp insulin with the pump.Tandem customer technical support informed customer that fiasp insulin is off-label per the user guide.Customer changed cartridge and infusion set to address the issue.

• 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 ; 858 224-6281
• MDR Report Key: 25670611
• Report Number: 3013756811-2026-117644
• Device Sequence Number: 20274854
• Product Code: QFG
• UDI-Device Identifier: 00389152706474
• UDI-Public: 00389152706474
• 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
• 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): 06/30/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 1017064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2026
• 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: FIASP - INSULIN; FIASP - INSULIN; TANDEM - CARTRIDGE; UNOMEDICAL - INFUSION SET; UNOMEDICAL - INFUSION SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 17 YR
• Patient Sex: Unknown