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

Model Number	1000354
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that pump displayed a cartridge change error and customer continued to receive alerts despite multiple attempts to change cartridge.There was no adverse impact to the customer¿s blood glucose level and it did not exceed 500 mg/dl.Customer inspected cartridge and pump area, removed extra o-ring, cleaned pump connection, and attempted to reload cartridge but was not able to complete load process; technical support escalated case, advised customer to contact healthcare provider or local hospital for backup insulin therapy, and csa later guided customer through loading new cartridge with room temperature insulin and new supplies, but error continued, customer stated they did not want to continue with tandem, ended call, and no further action was reported.
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 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: 50917137
• Report Number: 3013756811-2026-175936
• Device Sequence Number: 5777002
• Product Code: QFG
• UDI-Device Identifier: 00850006613793
• UDI-Public: (01)00850006613793(22)1006408(11)240717
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K201214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 1006408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Tandem - Cartridge; Tandem - Cartridge
• Patient Age: 29 YR
• Patient Sex: Female