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

Model Number	004628
Medical Device Problem Codes	Pumping Stopped (1503); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a cartridge was loose on the pump.A cartridge change was performed resolving the issue.Additionally, it was reported that a malfunction alarm occurred.During troubleshooting with technical support, the malfunction alarm was cleared, and insulin delivery was resumed successfully.There was no reported adverse impact to the customer's blood glucose level.
Additional Manufacturer Narrative
The device is expected to be returned; however, the device has not yet been received.A supplemental report will be submitted if the device is received, and evaluation is performed.

• Brand Name: T:SLIM INSULIN DELIVERY SYSTEM
• Common Device Name: INSULIN PUMP
• Manufacturer (Section D): TANDEM DIABETES CARE; 12400 high bluff drive; san diego CA 92130
• Manufacturer Contact: michael trier ; san diego, CA 92130 ; 8584011451
• MDR Report Key: 19510571
• Report Number: 3013756811-2024-102016
• Device Sequence Number: 15309530
• Product Code: LZG
• UDI-Device Identifier: 00852162004361
• UDI-Public: 00852162004361
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K111210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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
• Device Model Number: 004628
• Device Catalogue Number: 007435
• Device Lot Number: 60476569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2024
• Supplement Date Received by Manufacturer: 08/10/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2016
• 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: 42 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic