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	Incorrect Measurement (1383)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the insulin gauge was inaccurate, triggering an empty cartridge alarm despite the cartridge not being empty.As a result, customer's blood glucose (bg) level was elevated at 479 mg/dl and had to go to the emergency room.Customer was subsequently hospitalized in the intensive care unit where they were treated with intravenous fluids of saline and insulin.Treatment resolve the issue with no permanent damage to the customer.Multiple attempts were made by tandem technical support to follow-up with the customer on the reported issue as well as to obtain the date of release from the hospital, but no response was received.
Additional Manufacturer Narrative
In use at the time of the event: cgm model: unknown.Mobile os: 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: 50162104
• Report Number: 3013756811-2026-141956
• Device Sequence Number: 10034956
• Product Code: QFG
• UDI-Device Identifier: 00389152370019
• UDI-Public: (01)00389152370019(22)1013701(11)240808
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K233044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1004000
• Device Catalogue Number: 1013700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Tandem - Cartridge
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 19 YR
• Patient Sex: Unknown