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

Model Number	1002717
Medical Device Problem Code	False Alarm (1013)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pump declared altitude alarm and customer¿s blood glucose rose to a high level, although exact value was unknown, with insulin delivery suspended and no immediate corrective action taken by customer.Customer worked with technical support to remove and clean obstruction from speaker holes, reload cartridge, and attempt to resume insulin, but altitude alarm recurred, so technical support instructed customer to wait for moisture to evaporate; when issue persisted, pump and cartridge were replaced, customer was advised to use multiple daily injections as backup, and was given instructions for storage mode, pump return, and setting up replacement pump and connected devices.

• 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: 25461124
• Report Number: 3013756811-2026-104985
• Device Sequence Number: 21000362
• Product Code: QFG
• UDI-Device Identifier: 00389152286815
• UDI-Public: (01)00389152286815(22)1012965(11)231214
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 06/10/2026

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: 1002717
• Device Catalogue Number: 1012868
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2023
• 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: Other
• Patient Age: 33 YR
• Patient Sex: Male