MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	1000096
Medical Device Problem Code	False Alarm (1013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An altitude alarm was reported for a pump, causing the customer's insulin to be suspended.The customer's blood glucose level did not exceed 500 mg/dl, indicating there was no adverse impact.Technical support advised the customer to clean the speaker holes and attempt cartridge reconnection, but insulin delivery could not be resumed immediately.Eventually, the customer was instructed to load a new cartridge and resume insulin delivery, but the alarm persisted.An attempt was made by tandem technical support to follow-up with the customer on the reported issue, but no response was received.

• Brand Name: T:SLIM X2 INSULIN PUMP
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): TANDEM DIABETES CARE; 12400 high bluff drive; san diego CA 92130
• Manufacturer Contact: michael trier ; 12400 high bluff drive; san diego, CA 92130 ; 858 401-1451
• MDR Report Key: 22437132
• Report Number: 3013756811-2025-160522
• Device Sequence Number: 11910476
• Product Code: OYC
• UDI-Device Identifier: 00853052007295
• UDI-Public: 00853052007295
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P140015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1000096
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2017
• 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: 76 YR
• Patient Sex: Female