MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY; ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP

Catalog Number	1017064
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ongoing intermittent occlusion alarms occurred.Reportedly, the customer failed to complete the air removal step for cartridge.Tandem customer technical support educated customer to follow the proper air removal steps.Customer changed pump supplies to address the issue.There was no adverse impact to customer¿s blood glucose level.

• 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 ; 858 224-6281
• MDR Report Key: 25219549
• Report Number: 3013756811-2026-90254
• Device Sequence Number: 9792984
• Product Code: QFG
• UDI-Device Identifier: 00389152706474
• UDI-Public: 00389152706474
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K250792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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 Catalogue Number: 1017064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2026
• 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: OTHER - INSULIN; TANDEM - CARTRIDGE; UNOMEDICAL - INFUSION SET
• Patient Age: 14 YR
• Patient Sex: Unknown