MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM G4 SYSTEM; INSULIN INFUSION PUMP

Model Number	4628-003
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A cartridge change error was reported by the customer with their pump.There was no adverse impact on the customer's blood glucose level.Technical support instructed the customer to remove the cartridge, inspect the o-ring, and clean the pump area.Despite these steps and assistance from technical support, the customer was unable to successfully load a new cartridge.The issue was escalated to additional support, and it was determined that the customer needed a loaner pump.Customer service provided guidance on signing the loaner agreement and confirmed the return date for the temporary pump.

• Brand Name: T:SLIM G4 SYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): TANDEM DIABETES CARE; 12400 high bluff drive; san diego CA 92130
• Manufacturer Contact: michael trier ; 12400 high bluff drive; san diego, CA 92130 ; 858 401-1451
• MDR Report Key: 24003103
• Report Number: 3013756811-2026-04337
• Device Sequence Number: 10222694
• Product Code: OYC
• UDI-Device Identifier: 00852162004613
• UDI-Public: 00852162004613
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P140015
• 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): 01/08/2026

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: 4628-003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2026
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2019
• 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; TANDEM - CARTRIDGE; TANDEM - CARTRIDGE
• Patient Age: 21 YR
• Patient Sex: Male