IMPORTANT MEDICAL DEVICE SAFETY INFORMATION
Medtronic insulin pumps
July 24, 2014
The following warning and information applies to MMT-511, MMT-512/712/712E, MMT-515/715, MMT-522/522K/722/722K, MMT-523/523K/723/723K, and MMT-551/751 model insulin pump models.
Medtronic is conducting a voluntary recall to notify users of a button pressing error that can result in unintended insulin delivery and is reinforcing important information regarding the safe use of your Medtronic insulin pump.
Medtronic has received reports regarding users who have accidentally programmed the pump to deliver the maximum bolus amount, including one incident that resulted in severe hypoglycemia.
All insulin delivery settings that are programmed through the Main Menu (specifically, manual bolus, basal and temporary basal) can be inadvertently changed by pressing the down arrow button to scroll down from 0.0 units for bolus/basal or 0% (for temp basal deliveries), to the programmed maximum insulin dose. This may result in an accidental delivery of your maximum allowed insulin dose.
| Bolus Example | |
|---|---|
| A single press of the down arrow button moves the bolus amount from 0.0 units to 10.0 units (which is the default Max Bolus setting.) | Main Menu > Bolus Menu |
| Temp Basal % Example | |
|---|---|
| A single press of the down arrow button moves the temp basal amount from 0% to 200% (which is the highest temp basal rate.) | Main Menu > Basal > Temp Basal |
Accidental delivery of your maximum allowed dose could cause hypoglycemia (low blood sugar). Symptoms of low blood sugar may include trembling, excessive sweating, weakness, hunger, confusion, and headache. Severe low blood sugar with loss of consciousness, seizure, or death may occur.
If you realize you have accidently delivered an insulin dose that is higher than intended, you should call your healthcare professional immediately.
If the unintended delivery is still under way, manually suspend the pump to stop the delivery. Check the status screen to see how much insulin dose was delivered. If the delivered amount did not exceed your intended insulin dose, you can resume the pump delivery by following the User Guide.
Note: this accidental programming cannot occur when using the Express Bolus button to program a bolus. When using the
Express Bolus button 
to deliver a bolus, pressing the down arrow 
will scroll down to 0.0 and stop.
What action do I need to take?
- When programming insulin doses through the Main Menu, pay close attention because scrolling down allows the insulin dose displayed on the screen to go from 0.0 units (or 0%) to the maximum programmed insulin dose.
- Always confirm that the insulin dose flashing on the display is correct before pressing ACT to start delivery.
- Always ensure the Max Bolus and Max Basal safety limits programmed in your pump are set according to your personal insulin needs.
- If you would prefer a pump without the scroll around feature, you can call Medtronic to exchange your pump. 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 regarding this or any other matter regarding your Medtronic pump, please do not hesitate to contact the 24 Hour HelpLine at 1-866-222-7304.
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). |  |
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 
to deliver a bolus, the down arrow 
will scroll to 0.0 units and stop.
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.