MAUDE Adverse Event Report: Tandem Diabetes Care t:slim X2 Insulin Pump with Basal-IQ Technology; Alternate Controller Enabled Insulin Infusion Pump

Model Number	1000354
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that pump became hot to touch while charging, even though no temperature alarms were recorded, and customer was using tandem charging supplies.There was no adverse impact to the customer¿s blood glucose level.Customer planned to use multiple daily injections as backup insulin therapy.Technical support arranged shipment of replacement pump and advised customer to reprogram pump settings and reconnect continuous glucose monitor to replacement pump.
Additional Manufacturer Narrative
In use at the time of the event: cgm model: unknown.Mobile os: unknown / unknown / unknown / unknown.

• Brand Name: t:slim X2 Insulin Pump with Basal-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: 50323810
• Report Number: 3013756811-2026-150277
• Device Sequence Number: 21251408
• Product Code: QFG
• UDI-Device Identifier: 00389152000046
• UDI-Public: (01)00389152000046(22)1009640(11)250911
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K203234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 08/19/2026

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: 1000354
• Device Catalogue Number: 1010007
• 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: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2025
• 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: 62 YR
• Patient Sex: Female