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	Mechanical Problem (1384)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pump declared cartridge change error without alarm, and customer¿s blood glucose level exceeded 500 mg/dl with value displayed as ¿high.¿ customer experienced adverse impact to blood glucose level due to reported issue.Customer gave correction injection using multiple daily injections and did not require help from another person, then, with guidance from technical support, inspected cartridge o-ring and pump area, cleaned pneumatic tap, reattached cartridge, and followed on-screen steps to complete load process, after which customer successfully resumed insulin delivery.
Additional Manufacturer Narrative
In use at the time of the event: cgm model: unknown.Mobile os: unknown / unknown / unknown / unknown.

• 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: 50950752
• Report Number: 3013756811-2026-177976
• Device Sequence Number: 16063997
• Product Code: QFG
• UDI-Device Identifier: 00389152000077
• UDI-Public: (01)00389152000077(22)1009637(11)220821
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 1002717
• Device Catalogue Number: 1010009
• 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: 09/22/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2022
• 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: 44 YR
• Patient Sex: Male
• Patient Weight: 160 LB