MAUDE Adverse Event Report: Tandem Diabetes Care t:slim X2 Insulin Pump; Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

Model Number	1000354
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pump displayed a recurring occlusion alarm that could not be cleared, and caller stated that pump continued to give occlusion alarms when turned back on after being off in hospital.Reportedly, the customer reverted to an alternate method of insulin therapy.Customer¿s highest blood glucose related to incident was reported in the 400s mg/dl, with ketones, and there was no reported permanent injury.Customer first went to emergency room and was subsequently hospitalized in intensive care, received iv saline and insulin treatment that resolved issue, did not use pump while in hospital because pump was turned off, and cts was unable to complete further troubleshooting because pump was out of warranty and alarms would not clear, with no further cts action required.Customer was released from the hospital on (b)(6)2026.
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
• Common Device Name: Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
• 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: 50916779
• Report Number: 3013756811-2026-175906
• Device Sequence Number: 5344895
• Product Code: OYC
• UDI-Device Identifier: 00853052007318
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P140015
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1000354
• Device Catalogue Number: 1000911
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 25 YR
• Patient Sex: Unknown