MAUDE Adverse Event Report: Tandem Diabetes Care t:slim X2 Insulin Pump with Control-IQ+ Technology; Alternate Controller Enabled Insulin Infusion Pump

Model Number	1002717
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pump battery depleted too quickly, causing pump shutdown and leading customer to stop using pump for about a month, and customer later confirmed she had been on pump when she went to emergency room due to this issue.Customer did not know exact date of er visit but indicated it had occurred withing last 2 months.Customer¿s blood glucose reached 406 mg/dl and received saline and insulin through iv, and treatment resolved issue without permanent damage.Tandem technical support educated the customer about turning pump back on when it shuts down and reviewed logs which indicated that pump battery depletion is within normal parameters.
Additional Manufacturer Narrative
In use at the time of the event: cgm model: unknown mobile os: android / android_galaxy s20 fe 5g / unknown / android 16.

• 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 ; +1(858)224-6281
• MDR Report Key: 50159851
• Report Number: 3013756811-2026-141780
• Device Sequence Number: 9278355
• Product Code: QFG
• UDI-Device Identifier: 00850006613786
• UDI-Public: (01)00850006613786(11)220622
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K250792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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: 1002717
• Device Catalogue Number: 1006406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2022
• 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: 31 YR
• Patient Sex: Female
• Patient Weight: 233 LB