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	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that malfunction alarm malf 12 occurred on pump, with no notable events prior to the issue.There was no reported impact to the customer¿s blood glucose level.Customer planned to continue using current pump and rely on alternate method if needed until replacement arrived; technical support confirmed pump warranty and shipping details, instructed customer to place pump into storage mode and return pump within 10 days using provided packaging, and advised customer to reenter pump settings and reconnect continuous glucose monitor on replacement pump, while sending replacement pump to customer.
Additional Manufacturer Narrative
In use at the time of the event: cgm model: unknown.Mobile os: ios / ios_iphone 12 / unknown / ios 26.1.

• 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 ; +1(858)224-6281
• MDR Report Key: 50950151
• Report Number: 3013756811-2026-177967
• Device Sequence Number: 10452123
• Product Code: QFG
• UDI-Device Identifier: 00389152319513
• UDI-Public: (01)00389152319513(22)1012739(11)241212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K250792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 1002717
• Device Catalogue Number: 1013195
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2024
• 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
• Patient Age: 16 YR
• Patient Sex: Unknown