MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP); ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP

Model Number	1002717
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.H3 other text : device not returned.
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 manual injection 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.Recommendation was made to discuss diabetes management with a health care professional.

• Brand Name: T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
• 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: michael trier ; san diego, CA 92130 ; 8584011451
• MDR Report Key: 21504926
• Report Number: 3013756811-2025-44124
• Device Sequence Number: 17290821
• Product Code: QFG
• UDI-Device Identifier: 00850006613212
• UDI-Public: 00850006613212
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K203234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1002717
• Device Catalogue Number: 1005013
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2020
• 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
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic