Medtronic MMT-512, MMT-515, MMT-712E, MMT-712, MMT-715 User Manual

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 through the Main Menu

Building 9
Croxley Green Business Park
Hatters Lane
Watford, Herts WD18 8WW
Telephone: [phone]
Facsimile: 01923 241004

Medtronic Limited

18th March 2014 Medtronic Reference: FA606

Dear Medtronic Insulin Pump User:

With your health as our top priority, please take the time to review the safety information in this letter which applies 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.

Medtronic has received a small number of reports regarding users that have accidentally programmed the pump to
deliver the maximum bolus amount, including one incident that resulted in severe hypoglycemia.

How can this accidental programming occur?

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.

When using the Express Bolus button

Because accidental button pressing errors may occur, it is important that you always confirm the insulin dose

flashing on the display is correct before pressing ACT to start delivery.

What Safety Settings will minimize the risk of an accidental programming error?

Always ensure the Max Bolus and Max Basal safety limits are programmed in your pump according to your personal
insulin needs. Your healthcare professional will help determine appropriate settings for you. See the User Guide or
second page of this letter for instructions on how to program these settings.

What action do I need to take?

1. Pay close attention when programming insulin doses through the Main Menu, 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 correct insulin dose is flashing on the display before pressing ACT to start delivery.

Medtronic Limited is a wholly owned subsidiary of Medtronic Inc. whose registered office is Building 9, Croxley Green Business Park, Hatters

Lane, Watford, Herts WD18 8WW. Registered in England No. 1070807

Page 1 of 2

to deliver a bolus, the down arrow

will scroll to 0.0 units and stop.

3. Verify your Max Bolus and Max Basal settings are programmed according to your personal insulin needs, per

your healthcare professional’s instructions.

To set the maximum bolus limit:

The Maximum bolus (Max bolus) is a safety feature that limits the amount of insulin that can be delivered in a
single bolus. It is important to discuss this feature with your healthcare professional to determine your Max bolus
amount.

Go to the MAX BOLUS SETUP screen.

For Paradigm MMT-523/MMT-723/MMT-523K/MMT-723K and MMT-554/MMT-754 (Veo):
1 Main > Bolus > Bolus Setup > Max Bolus
2 Set your Max bolus limit and press ACT
3 Your Max bolus is set. Exit the menus

All other Paradigm Pump models:

1 Main > Bolus > Max Bolus
2 Set your Max bolus limit and press ACT
3 Your Max bolus is set. Exit the menus

Setting the Max basal rate:

It is important to determine your Max basal rates with your healthcare professional. This safety feature will not
allow you to program any basal rates, including patterns and temporary basal rates that are greater than the Max
basal rate.

Go to the MAX BASAL RATE screen.

For Paradigm MMT-523/MMT-723/MMT-523K/MMT-723K and MMT-554/MMT-754 (Veo):
1 Main > Basal > Basal Setup > Max Basal Rate
2 Change the rate and press ACT
3 Your Max basal rate is now set. Exit the menus

All other Paradigm Pump models:
1 Main > Basal > Max Basal Rate
2 Change the rate and press ACT
3 Your Max basal rate is now set. Exit the menus

Medtronic is committed to keeping you and your healthcare professional informed of issues and solutions concerning
our products and services. Should you have any questions about this or any other matter regarding your Medtronic
pump, please do not hesitate to contact the 24-Hour Helpline on [phone].

We appreciate your time and attention to this important notification.

Yours sincerely,

David G Dunham BSc, PhD
Regulatory Affairs & Quality Manager – UK & Ireland

Page 2 of 2