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	Hyperglycemia (1905)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that ongoing intermittent occlusion alarms occurred, leading to the customer experiencing intermittent high blood glucose (bg) levels.The customer¿s bg level was displayed as ¿high¿; however, a specific value was not provided.The elevated bg was addressed by a correction injection via manual insulin therapy.Customer resolved the issue by changing the infusion set and cartridge.No assistance from a third party was required.Reportedly, the customer continued to use the pump for insulin therapy.

• 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: 24738227
• Report Number: 3013756811-2026-58369
• Device Sequence Number: 17461972
• Product Code: QFG
• UDI-Device Identifier: 00389152480114
• UDI-Public: (01)00389152480114(22)1016588(11)250422
• Combination Product (Y/N): N
• PMA/510(K) Number: K240309
• 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,Followup
• Report Date (Section B): 05/26/2026

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: 1014801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 05/23/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 20 YR
• Patient Sex: Unknown