MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY; ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP

Model Number	1000096
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperglycemia (1905); Loss of consciousness (2418)
Date of Event	06/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the control-iq algorithm suspended basal delivery in response to the continuous glucose monitor (cgm) sensor reading; however, the cgm sensor reading was inaccurate.Reportedly, the cgm blood glucose (bg) reading was a level that was displayed as ¿low¿; however, a specific value was not provided, and the contact was unable to provide a meter bg reading at the time of the event.As a result of the basal suspension and customer treating a false low, customer's blood glucose (bg) rose and experienced diabetic ketosis.Highest bg level was not provided at time of the event.Due to the elevated bg level the customer loss consciousness.Customer went to the emergency room (er) and was admitted into the intensive care unit.Customer was treated with intravenous fluids of insulin and saline and was released from the hospital on (b)(6) 2025.Multiple contact attempts were made by tandem technical support to obtain additional information regarding the issue; however, the customer did not respond.No additional patient or event information was available.

• Brand Name: T:SLIM X2 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 ; 858 224-6281
• MDR Report Key: 24511858
• Report Number: 3013756811-2026-40910
• Device Sequence Number: 15942594
• Product Code: QFG
• UDI-Device Identifier: 00853052007295
• UDI-Public: (01)00853052007295
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K201214
• 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): 03/04/2026

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: 1000096
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2018
• 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; Hospitalization; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Female