• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Tandem Diabetes warns on some t:slim X2 insulin pumps

March 8, 2022 By Sean Whooley

Tandem Diabetes CareTandem Diabetes Care (Nasdaq:TNDM) issued an urgent field safety notice in Europe for its t:slim X2 insulin pump with Basal-IQ technology.

The notice, dated February 2022, alerts users of Tandem’s insulin pump with a software version of 6.3.0.1 that there may be a potential safety risk when using the pump within its normal specifications. Tandem’s t:slim X2 with Control-IQ technology is not affected.

According to the notice, Tandem’s insulin pumps include a “Personal Profile” feature that allows users to personalize the settings that define the delivery of basal and bolus insulin within specific time segments in a 24-hour period. After a user inputs a basal rate into the screen, a “Confirm Settings?” screen is displayed and must be acknowledged, but a user could inadvertently program and confirm a basal rate with an incorrectly placed decimal point.

Inputting incorrect values can lead to under-delivery or over-delivery of insulin, which could result in hyperglycemia or hypoglycemia. Users have been informed by Tandem that they can continue using the pump with extra precautions:

  • Take extra care when creating or editing your personal profile.
  • Confirm the basal rate change was correctly entered in the “Confirm Settings?” page.
  • Double-check all values entered before advancing past “Confirm Settings?”
  • Regularly check blood sugar to ensure that levels are not unexpectedly high or low.

Tandem will be releasing a t:slim X2 with Basal-IQ technology software update that rectifies the issues noted above, while the company has already implemented an additional feature called “Basal Limit” on the t:slim X2 with Control-IQ technology insulin pumps.

Filed Under: Auto-injectors, Diabetes, Drug-Device Combinations, Featured, Recalls, Regulatory/Compliance, Technology Tagged With: Tandem Diabetes Care

IN CASE YOU MISSED IT

  • Nuvo, Sheba Medical Center develop AI-powered gestational diabetes management platform
  • Verily’s Onduo, Sword Health collaborate on virtual diabetes care
  • Shareholder lawsuit over BD’s Alaris pumps recall moves forward
  • Embecta stock soars on first full-quarter results after BD spinoff
  • Abbott will spend $450M to up FreeStyle Libre production in Ireland

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Signup for the newsletter

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing & Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS