MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number 1000354

Device Problems Filling Problem (1233); Obstruction of Flow (2423)

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

Event Date 10/27/2022

Event Type  malfunction  

Event Description

It was reported that an occlusion alarm occurred.Reportedly, the customer had been using fiasp insulin within the pump supplies.Tandem customer technical support informed customer that fiasp insulin is off label per the user guide.Additionally, it was reported that insulin drips were not observed to be exiting the infusion set tubing during the load fill tubing process.Reportedly, customer is not performing the air removal process.Tandem customer technical support informed customer not performing the air removal steps is off label per the tandem user guide.Reportedly, a supply change was performed to address the issue and insulin delivery was resumed.Customer¿s blood glucose level was 117 mg/dl.

Manufacturer Narrative

No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.Per tandem user guide: do not use any other insulin with your system other than u-100 humalog® or novolog®.Only humalog® and novolog® have been tested and found to be compatible for use in the system.Use of insulin with lesser or greater concentration can result in under delivery or over delivery of insulin.This can cause very high or a very low blood glucose.Per tandem user guide: always remove all air bubbles from the system 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.

• Brand Name: T:SLIM X2 INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): TANDEM DIABETES CARE; 11075 roselle street; san diego CA 92121
• Manufacturer Contact: michael trier ; 8584011451
• MDR Report Key: 15817413
• MDR Text Key: 307308803
• Report Number: 3013756811-2022-127007
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00853052007981
• UDI-Public: (01)00853052007981
• 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
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1000354
• Device Catalogue Number: 1003808
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2019
• 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: FIASPINFUSION SET: AUTOSOFT XC
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic