Insulin Delivery Programming Through Main Menu & New Button Update

Insulin Delivery Programming Through Main Menu & New Button Update

IMPORTANT MEDICAL DEVICE SAFETY INFORMATION

Insulin Delivery Programming Through Main Menu & New Button Update, 3/17/14
Download important safety information for all Paradigm® insulin pump models, as well as the MiniMed® 530G Download >

As part of our commitment to keep customers informed of issues and solutions concerning our products and services, Medtronic is contacting all global insulin pump customers to reinforce important information about programming insulin delivery amounts and to provide a product update.

When programming insulin delivery through the pump’s Main Menu, it is possible to scroll down from zero to the maximum insulin dose. This could cause someone to deliver more insulin than intended, which could result in severe hypoglycemia (low blood glucose).

No products need to be returned because of this potential issue. The use of Medtronic insulin pumps is safe when used according to the instructions and we’ve received very few reports about this issue. However, because customer safety is our top priority, we are contacting you to remind you of the steps you can take to avoid accidental button pressing errors including:

  1. When programming insulin doses through the Main Menu, pay close attention because scrolling down allows the dose displayed on the screen to go from 0.0 units to the maximum programmed insulin dose.
  2. Always confirm the insulin dose that is flashing on the display is correct before pressing ACT to start delivery.
  3. Make sure your maximum insulin dose settings are programmed according to your personal insulin needs, per your healthcare professional’s instructions.

In addition, based on feedback we’ve received from our customers, we’re letting you know about improvements we’re making to the keypad, which are designed to reduce button error alarms and improve button response. These improvements are being incorporated into the manufacturing of insulin pumps in the coming months.

We thank you, our customers, for continuing to put their trust in us and encourage anyone with questions to contact Medtronic 24 hours-a-day at (1-800-646-4633).



Medtronic Insulin Pumps, 7/24/14
Important safety information for Medtronic Insulin Pumps
Medtronic MiniMed 530G, 10/7/13
Important safety information for MiniMed 530G®
Medtronic Paradigm Reservoirs, 7/5/13
Important safety information for Paradigm® Reservoirs
FAQs
Q
Why did Medtronic change the keypad on the insulin pump? >
A