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

Model Number	1004000
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported a tandem mobi cartridge alarm, which occurred during the load process despite following the mobile app's prompt to remove and load a new cartridge.The customer's blood glucose level did not exceed 500 mg/dl, indicating no adverse impact on the blood glucose level.Technical support confirmed the cartridge alarm and decided to replace the pump.The customer requested a replacement with a tslim pump and expressed a desire to speak with a higher authority; therefore, the case was transferred to customer support.

• Brand Name: TANDEM MOBI 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: michael trier ; 12400 high bluff drive; san diego, CA 92130 ; 858 401-1451
• MDR Report Key: 23097421
• Report Number: 3013756811-2025-220271
• Device Sequence Number: 15636129
• Product Code: QFG
• UDI-Device Identifier: 00389152271910
• UDI-Public: 00389152271910
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K240309
• 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): 09/19/2025

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: 1004000
• Device Catalogue Number: 1012719
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2024
• 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
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 95 KG