Important medical device safety information


Insulin Delivery Programming Through Main Menu & New Button Update


Download important safety information for all Paradigm® insulin pump models, as well as the MiniMed® 530G Download

3/17/14

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

Frequently asked questions


We understand that communications such as these can be concerning. Since your safety is our number one priority, it is important for us to keep you informed of potential issues so you know what we do – in this case, making you aware of a button pressing error that can result in accidentally delivering too much insulin to yourself, and to reinforce important information regarding the safe use of your Medtronic insulin pump. Please refer to the letter you received for important information about the potential for accidental over delivery of insulin. The instructions are as follows:


  • Always ensure the Max Bolus and Max Basal safety limits programmed in your pump are set according to your personal insulin needs. Your healthcare professional will help you determine the settings that are right for you. (See the User Guide for instructions on how to program these settings, which can also be found at www.medtronicdiabetes.com, navigate to Support> Settings & Features.)
  • When programming insulin doses through the Main Menu, pay close attention because scrolling down from 0.0 units will display the maximum programmed insulin dose.
  • Always confirm the insulin dose that is flashing on the display is correct before pressing ACT to start delivery.
  • If you would prefer a pump without the scroll around feature, you can call Medtronic to exchange your pump at 1-866-222-7304.

All insulin delivery programmed through the Main Menu will allow the down arrow button to scroll from 0.0 units to the programmed maximum insulin dose. This can occur while programming insulin delivery through the Main Menu. This feature was designed for convenience, allowing users to scroll down to the minimum value and then continue scrolling down to “wrap-around” to the maximum value, similar to entering time on a digital clock.

Bolus Example
A single press of the down arrow button will move the bolus from 0.0 units to the programmed Max Bolus (the default Max Bolus is 10.0 units). Bolus Example

As described in your User Guide, all Medtronic pumps require a confirmation press of the ACT button as the final step to start delivery. Because accidental button pressing errors may occur, it is important that you always verify that the insulin dose that is flashing on the display screen is correct before pressing ACT to start delivery.

It is important to know that when using the Express Bolus button Express Bolus button to deliver a bolus, the down arrow Down Arrow button will scroll to 0.0 units and stop.

No, you do not need to return your insulin pump. We just want you to be aware of these important instructions.
Yes. This communication is related to the following Medtronic insulin pump models -
  • Paradigm: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754.
  • MiniMed 530G: MMT-551 and MMT-751.
As part of our ongoing quality process, we recently discovered a small number of reports from customers who have accidently programmed the pump to deliver the maximum bolus amount. Medtronic continually evaluates feedback we receive from customers through the 24-Hour HelpLine and other channels about situations they encounter with Medtronic products.
Yes, we are notifying your doctor about this important information.
This field notification involves all Paradigm infusion sets, including the Quick-set, Silhouette, Sure-T, Mio, Polyfin, and Sof-set. If needed: This field notification involves MMT-317, MMT-318, MMT-324, MMT-325, MMT-312S, MMT-312L, MMT-386, MMT-387, MMT-394, MMT-396, MMT-397, MMT-398, MMT-399, MMT-377, MMT-378, MMT-381, MMT-382, MMT-383, MMT-384, MMT-368, MMT-862, MMT-864, MMT-866, MMT-874, MMT-876, MMT-884, MMT-886, MMT-921, MMT-923, MMT-925, MMT-941, MMT-943, MMT-945, MMT-961, MMT-963, MMT-965, & MMT-975 Paradigm infusion sets.
Yes. The use of the Paradigm reservoirs and infusion sets in the Paradigm pumps are safe when the reservoir fill process and priming procedures are followed according to the instructions. Since your safety is our number one priority, we work hard to keep you informed of potential issues. In this case, we wanted to make sure that you understand the importance of following the instructions on how to fill your reservoir. As long as liquid does not get on the inside of the tubing connector, you don’t need to be concerned. (Refer to instructions in the letter as needed.)
Since your safety is our number one priority, we work hard to keep you informed of potential issues. We are notifying you to remind you about this important information about the reservoir fill process, which includes holding the insulin vial upright when you remove the reservoir, and avoiding getting the reservoir and tubing connector wet. It’s important to note that when the reservoir fill process and priming procedures are followed according to the instructions, the Paradigm reservoirs and infusion sets in the Paradigm pumps should work as they are supposed to.
Yes, we are notifying your doctor about this important information.
Medtronic insulin pumps are safe when used according to the instructions. Because we’ve received a small number of reports from people who accidently gave themselves the Max Bolus, we are notifying you to ensure you understand this important information as well as steps to help you avoid the situation. The safety of customers like you is our top priority.
Based on feedback we’ve received from our customers we have made improvements to the keypad of our insulin pump which has been 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.
No. The scrolling feature was designed for convenience, allowing users to scroll down to the minimum value and then continue scrolling down to “wrap-around” to the maximum value, similar to entering time on a digital clock.