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

Model Number	1004484
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Pumps returned from a clinical trial were reported to have mal-16 failures and were flagged for quality issues.There was no adverse impact to the customer's blood glucose level.The pumps were quarantined by the qa team once the return process was initiated and completed, and the list of pumps was updated to reflect the correct number involved.

• 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: 22298679
• Report Number: 3013756811-2025-150758
• Device Sequence Number: 9227709
• Product Code: LZG
• UDI-Device Identifier: 00852162004590
• UDI-Public: 00852162004590
• Combination Product (Y/N): N
• 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): 06/20/2025

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: 1004484
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown