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

Model Number	1000354
Medical Device Problem Code	False Alarm (1013)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pump repeatedly displayed altitude alarm and suspended insulin delivery over past month while within normal operating altitude.Customer¿s blood glucose level exceeded 500 mg/dl and meter displayed ¿high¿; specific value was unknown.Customer initially took no action for high blood glucose.Technical support guided customer to clean speaker holes with soft brush and lint-free cloth, remove and reconnect cartridge, and wait for insulin to resume, after which insulin delivery restarted and altitude alarm did not recur.Pump resumed normal operation, insulin remained active, and customer received instructions on preventing future altitude alarms.
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: 50950360
• Report Number: 3013756811-2026-177969
• Device Sequence Number: 9499355
• Product Code: QFG
• UDI-Device Identifier: 00389152319810
• UDI-Public: (01)00389152319810(22)1012742(11)241217
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K232380
• 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: 1000354
• Device Catalogue Number: 1013198
• 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: 09/18/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2024
• 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: 63 YR
• Patient Sex: Female