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

Model Number 1000096

Device Problem Partial Blockage (1065)

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

Event Date 04/30/2021

Event Type  malfunction  

Manufacturer Narrative

Per the tandem user guide, "always remove all air bubbles from the pump before beginning insulin delivery.Ensure there are no air bubbles when drawing insulin into the filling syringe, hold the pump with the white fill port pointed up when filling the tubing, and ensure that there are no air bubbles in the tubing when filling.Air in the system takes space where insulin should be and can affect insulin delivery." no product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that air bubbles were observed in the infusion set tubing.Reportedly, the customer had not performed the air removal process correctly prior to filling the cartridge with insulin.The customer's blood glucose level was 116 mg/dl.Customer changed the pump supplies to resolve the issue.

• 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: mick trier ; san diego, CA 92121 ; 8584011451
• MDR Report Key: 11848600
• MDR Text Key: 251422435
• Report Number: 3013756811-2021-52646
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 00852162004798
• UDI-Public: (01)00852162004798
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2021

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 Operator: No Information
• Device Model Number: 1000096
• Device Catalogue Number: 1000369
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 05/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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
• Treatment: INSULIN TYPE: HUMALOGINFUSION SET: VARISOFT
• Patient Age: 75 YR