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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer experienced a blood glucose (bg) level that was displayed as ¿high¿; however, a specific value was not provided.Reportedly, the customer alleged the pump software did not accurately adjust the amount of insulin delivered resulting in the high bg.Customer gave a correction bolus via the pump to address bg level.Tandem technical support (cts) performed a system check and performed a review of the pump data to determine a possible cause.Cts determined that the pump functioned as intended and the cause of the high bg was unknown, customer acknowledged and understood.
Additional Manufacturer Narrative
In use at the time of the event: cgm model: g6.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: 50923333
• Report Number: 3013756811-2026-176275
• Device Sequence Number: 5804440
• Product Code: QFG
• UDI-Device Identifier: 00389152370019
• UDI-Public: (01)00389152370019(22)1013701(11)240720
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/28/2026

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?: No
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 YR
• Patient Sex: Unknown