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	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customer experienced ongoing occlusion alarms on pump despite multiple troubleshooting attempts, including changing supplies, using longer cannula, and cleaning vents and tap, and caller confirmed occlusion alarm on reported event date.There was no adverse impact to the customer¿s blood glucose level.Customer resumed insulin therapy, was advised on how to continue using current pump and follow backup plan if needed, and technical support arranged pump replacement, instructed customer to place pump in storage mode, return pump properly, and watch for tracking email, with case closed after replacement was approved.
Additional Manufacturer Narrative
In use at the time of the event: cgm model: unknown mobile os: ios / ios_iphone 8 plus / unknown / ios_14.5.1.

• 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: 50950223
• Report Number: 3013756811-2026-177968
• Device Sequence Number: 10429695
• Product Code: QFG
• UDI-Device Identifier: 00389152000091
• UDI-Public: (01)00389152000091(22)1009641(11)230509
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: 1010011
• 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: 09/24/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2023
• 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: Humalog - Insulin
• Patient Age: 72 YR
• Patient Sex: Female