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	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customer experienced repeated occlusion alarms on mobi pump over several months, including active alarms that recurred during troubleshooting and were associated with supply changes, though customer did not report issues with infusion sites or insulin.There was no adverse impact to the customer¿s blood glucose level.Customer followed technical support instructions to disconnect tubing, adjust connections, and deliver test boluses, and clinical support recommended pump replacement; customer was advised to use multiple daily injections until replacement pump arrived, was given education on putting pump in storage mode and returning pump, and tandem technical support proceeded with arranging replacement and follow-up.
Additional Manufacturer Narrative
In use at the time of the event: cgm model: unknown mobile os: unknown / unknown / unknown.

• 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: john connell ; 12400 high bluff drive; san diego, CA 92130 ; +1(858)224-6281
• MDR Report Key: 50948791
• Report Number: 3013756811-2026-177847
• Device Sequence Number: 9534345
• Product Code: QFG
• UDI-Device Identifier: 00389152365510
• UDI-Public: (01)00389152365510(22)1013457(11)250312
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K240309
• 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: 1004000
• Device Catalogue Number: 1013655
• 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: 03/12/2025
• 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: 70 YR
• Patient Sex: Male