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	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a minimum fill notification occurred while customer attempted to load new cartridge.There was no adverse impact to the customer¿s blood glucose level.Customer cleaned pneumatic tap area as instructed by technical support, reloaded same cartridge with usable insulin, and successfully loaded cartridge onto pump and resumed insulin delivery.

• 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: john connell ; 12400 high bluff drive; san diego, CA 92130 ; 858 224-6281
• MDR Report Key: 25101912
• Report Number: 3013756811-2026-82507
• Device Sequence Number: 12019722
• Product Code: OYC
• UDI-Device Identifier: 00853052007257
• UDI-Public: (01)00853052007257
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/06/2026

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: 05/03/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNOMEDICAL - INFUSION SET
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 57 KG