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

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Diabetes: New warnings for Medtronic’s Paradigm insulin pumps

Diabetes: New warnings for Medtronic’s Paradigm insulin pumps

April 14, 2014 By Arezu Sarvestani

Diabetes: New warnings for Medtronic's Paradigm insulin pumps

Australian healthcare regulators issued renewed warnings to patients using Medtronic’s (NYSE:MDT) Paradigm insulin pumps, cautioning that an accidental button-press may result in a potentially dangerous overdose.

The Paradigm pumps, which deliver both continuous and bolus-based doses of insulin, can switch from a zero bolus setting to a maximum dose with a single click when in certain modes. An accidental press of the button may result in a patient mistakenly dispensing the maximum dose of insulin.

A small number of overdoses have already been reported, with one patient hospitalized for severe hypoglycemia, according to the warning. Medtronic has taken steps to warn patients and healthcare providers, a move that Australian regulators sought to reinforce with new warnings.

The Paradigm pumps have been the subject of warnings in the past. In July 2013 the FDA put its highest-risk Class I label on a recall of Paradigm and Polyfin insulin pumps, issued over concerns that the devices may over- or under-deliver insulin if certain components are contaminated with insulin or other fluids. One month earlier Medtronic’s Canada division announced that it received 2 reports associating its Paradigm and Polyfin infusion pumps with instances of under- or over-delivery of insulin.

Just over a year ago Australian regulators warned of 3 potential safety issues associated with the Paradigm pumps, adding that "these issues are rare and it is unlikely that you will need to replace your Medtronic Paradigm Insulin Pump."

Issues included loose support caps, a sensor graph timeout and the dangers of exposure to water damage.

Medtronic’s stock lost few points on Wall Street today after the medtech titan was hit with a major loss against arch-rival Edwards Lifesciences (NYSE:EW). MDT shares were down 2% to $57.98 as of about 2 p.m. EST.

Filed Under: News Well, Recalls Tagged With: Australia Therapeutic Goods Administration, Insulin Management, Minnesota

More recent news

  • Breaking: Sequel to launch twiist automated insulin delivery system next month
  • Dexcom shares U.S. report on CGM benefits for type 2 diabetes
  • Data backs Medtronic MiniMed 780G for type 2, children as company seeks expanded indications
  • Endogenex data supports type 2 diabetes procedure
  • Ambu wins FDA clearance for first single-use cysto-nephroscope

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock 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.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · 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.

Privacy Policy