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	Hyperglycemia (1905)
Date of Event	09/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pump displayed undertravel stall malfunction alarm, and blood glucose meter showed high value above meter range.Customer¿s blood glucose level exceeded 500 mg/dl, with exact value unknown.Customer gave correction insulin injection using multiple daily injections, switched to backup multiple daily injection therapy, and did not seek help from a third party.Technical support arranged replacement pump with updated software, confirmed shipping details, provided instructions for storage mode and pump return, and advised customer to enter pump settings and reconnect continuous glucose monitor on replacement pump.
Additional Manufacturer Narrative
In use at the time of the event: cgm model: unknown.Mobile os: android / android_galaxy s20 fe 5g / android 16.

• 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: 50915759
• Report Number: 3013756811-2026-175835
• Device Sequence Number: 14788527
• Product Code: QFG
• UDI-Device Identifier: 00389152370019
• UDI-Public: (01)00389152370019(22)1013701(11)240529
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/28/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1004000
• Device Catalogue Number: 1013700
• 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: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2024
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 195 LB