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

Model Number	1000096
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device issue occurred when the customer woke up to a notification that no insulin was available, despite having completed a load operation less than 24 hours earlier.The customer attempted to reload the device and reset it without success and suspected the possibility of the device being non-functional due to it being out of warranty for some time.The customer needed a new device urgently.Customer support attempted to troubleshoot the issue and followed up with the customer but was unable to resolve the issue, ultimately closing the case after all follow-up attempts were exhausted.There was no reported impact on the customer¿s blood glucose level.

• 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: 24567876
• Report Number: 3013756811-2026-45212
• Device Sequence Number: 9500108
• Product Code: QFG
• UDI-Device Identifier: 00853052007257
• UDI-Public: (01)00853052007257
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1000096
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2018
• 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
• Patient Age: 35 YR
• Patient Sex: Male