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	03/30/2026
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; cause was unknown.Customer gave a manual injection to address bg level.The customer declined assistance from tandem technical support regarding the issue.No additional patient or event information was available.

• 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 ; 858 224-62
• MDR Report Key: 24741759
• Report Number: 3013756811-2026-58503
• Device Sequence Number: 19687069
• Product Code: QFG
• UDI-Device Identifier: 00389152481111
• UDI-Public: (01)00389152481111(22)1017800(11)251124
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K241078
• 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): 03/31/2026

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: 1014811
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HUMALOG - INSULIN; TANDEM - CARTRIDGE; UNOMEDICAL - INFUSION SET; UNOMEDICAL - INFUSION SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 12 YR
• Patient Sex: Male