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	False Alarm (1013)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pump declared altitude alarm and insulin delivery was suspended, and customer¿s blood glucose level was displayed as ¿high¿ above 500 mg/dl.There was an adverse impact to the customer¿s blood glucose level, but specific value was not known.Customer initially took no action and did not seek third-party assistance, while cts provided instructions to clean speaker area, remove and reconnect cartridge, and attempt to resume insulin, which was not successful until customer loaded new cartridge and waited 2 hours for moisture to evaporate.After 2 hours, customer was able to load new cartridge, resume insulin delivery, and pump returned to normal operation, and cts explained likely exposure to condensation or humidity, gave tips to prevent altitude alarms, and closed case with no further action required.
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: 50950350
• Report Number: 3013756811-2026-177972
• Device Sequence Number: 9499353
• Product Code: QFG
• UDI-Device Identifier: 00389152000091
• UDI-Public: (01)00389152000091(22)1009641(11)220915
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 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: 1010011
• 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: 09/17/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2022
• 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: 25 YR
• Patient Sex: Female