MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM INSULIN DELIVERY SYSTEM; INSULIN INFUSION PUMP

Model Number	004628
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Jacob chappell reported battery drainage.There was no reported impact on jacob's blood glucose level.Jacob declined additional follow-up, and no further actions or outcomes were detailed.

• Brand Name: T:SLIM INSULIN DELIVERY SYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• 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: 22872202
• Report Number: 3013756811-2025-199211
• Device Sequence Number: 10386557
• Product Code: LZG
• UDI-Device Identifier: 00852162004545
• UDI-Public: 00852162004545
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K160056
• 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): 08/22/2025

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: 004628
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2018
• 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
• Patient Age: 24 YR
• Patient Sex: Male