Page 1
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: 01923 212213
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
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to deliver a bolus, the down arrow
will scroll to 0.0 units and stop.
Page 2
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 +44 (0)1923 212213.
We appreciate your time and attention to this important notification.
Yours sincerely,
David G Dunham BSc, PhD
Regulatory Affairs & Quality Manager – UK & Ireland
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Page 3
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: 01923 212213
Facsimile: 01923 241004
Medtronic Limited
Urgent Field Safety Notice
Paradigm Pump Models 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.
Recommendations for scrolling when selecting insulin delivery amounts
17th March 2014 Medtronic Reference: FA606
Dear Healthcare Professional:
We are sending this letter to reinforce important information regarding the safe use of Medtronic insulin pumps and to
provide a product update. Medtronic is informing directly patients for which we have contact details. Because
Medtronic does not have your patients’ records on file, we kindly ask you to inform Paradigm pump users
using the enclosed letter.
Medtronic has received a small number of reports regarding users who have accidentally programmed the pump to
deliver the maximum bolus amount, including one incident that resulted in severe hypoglycaemia.
With your patient’s 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.
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
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.
Page 4
Because accidental button pressing errors may occur, it is important that patients 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?
The Max Bolus and Max Basal safety limits should be programmed in your patients’ pumps according to their
individual insulin needs. See the User Guide for instructions on how to program these settings.
What action do I need to reinforce with my patients?
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 flashing on the display is correct before pressing ACT to start delivery.
3. Make sure the Max Bolus and Max Basal settings are programmed according to individual insulin needs.
The Medicines and Healthcare products Regulatory Agency (MHRA) has been notified of this action. This notice
needs to be passed on all those who need to be aware within your organization.
We appreciate your time and attention to this important notification. A copy of the pump user letter is also included for
your reference.
.
Yours sincerely,
David G Dunham BSc, PhD
Regulatory Affairs & Quality Manager – UK & Ireland
Enclosure: Dear Pump User Letter
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