• 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

Insulet’s Omnipod Dash Personal Diabetes Managers have a glitch

February 13, 2020 By Chris Newmarker

Insulet Ominipod Dash Personal Diabetes Managers
The smartphone-like Personal Diabetes Manager [PDM] is supposed to enable an Omnipod Dash user to conveniently and discreetly communicate with their Podd. [Image courtesy of Insulet]
Insulet (NSDQ:PODD) is issuing a voluntary medical device correction for all of the smartphone-like Personal Diabetes Managers that came with its next-gen Omnipod Dash insulin management system, the company announced today.

During its ongoing quality management process, Insulet officials discovered that the PDMs on rare occasions will suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old. The error takes place when a user does not exit the bolus calculator — as designed — or when a system alarm interrupts a bolus calculation.

An inaccurate bolus is a serious matter because too much insulin can be potentially deadly. Insulet said it has no reports of injuries at this time. It said the Omnipad Dash system is still safe to use.

The Acton, Mass.–based company is sending emails and letters to all affected Omnipod Dash users to warn them about the software bug — with replacement PDMs becoming available next month. The company did not disclose how many PDMs are presently out there.

The Street so far today appears to be reacting positively to how Insulet is handling the problem, with PODD shares up more than 2% to $206.20 apiece at midday trading.

Insulet received FDA 510(k) clearance for the Omnipod Dash in June 2018 and launched the device last year.

 

 

Filed Under: Diabetes, Drug-Device Combinations, Featured, mHealth (Mobile Health), Recalls Tagged With: Insulet, insulin

IN CASE YOU MISSED IT

  • Abbott will spend $450M to up FreeStyle Libre production in Ireland
  • Better Therapeutics Q2 beats Street as it prepares to submit diabetes therapy for FDA review
  • Study backs Fluidx embolic device for vessel filling
  • Senseonics stock is up as it sticks by revenue guidance
  • Rapid Dose closes first tranche of $5M financing

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