MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP

Model Number 1000096

Device Problems Poor Quality Image (1408); Pumping Stopped (1503); Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2023

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.Device not returned.

Event Description

It was reported that the pump battery was depleting quickly resulting in the pump shutting down.Additionally, it was reported that the pump's touchscreen was difficult to see and that the wake button was unresponsive.There was no reported adverse impact to the customer's blood glucose level.Customer declined to troubleshoot with tandem technical support, therefore no additional information could be obtained.

Manufacturer Narrative

D1, d2b, g4.

• Brand Name: T:SLIM X2 INSULIN PUMP
• Type of Device: INSULIN PUMP
• Manufacturer (Section D): TANDEM DIABETES CARE; 11075 roselle street; san diego CA 92121
• Manufacturer Contact: michael trier ; 8584011451
• MDR Report Key: 16282921
• MDR Text Key: 308619832
• Report Number: 3013756811-2023-12020
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 00852162004781
• UDI-Public: (01)00852162004781
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1000096
• Device Catalogue Number: 1000103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Female
• Patient Weight: 35 KG
• Patient Ethnicity: Non Hispanic