Urgent Field Safety Notification


MiniMed™ 600 series insulin infusion pump


Download important safety information for the MiniMed™ 600 Series Insulin Infusion Pump Temporary Unresponsive Keypad Download

This notification is to inform you of a rare and temporary condition in which the keypad buttons on your MiniMed™ 600 series insulin pump may become temporarily stuck, and the keypad becomes unresponsive. This is a field safety notification and you do not need to return or replace your pump. We do ask that you read the important information below to help you understand when this situation might happen, and how to resolve it.

How does the keypad become temporarily unresponsive?

Keypad buttons on the MiniMed™ 600 series insulin pumps may become temporarily unresponsive when the atmospheric pressure around the pump increases or decreases rapidly. This would most likely happen when traveling in an airplane during take-off or landing. If this happens, in most cases you may not even notice because the pump will resolve this on its own.

How will I notice if this happens to my pump?

During this temporary situation, a button may be too difficult to press down or a button can look like it is pressed and stuck in that position.

If you notice the keypad buttons are difficult to press down, the pump will continue to deliver your basal insulin. You may not be able to program a bolus or suspend delivery as the buttons temporarily will not press down, but this will resolve on its own, usually within 30 minutes.

If a button is stuck in a pressed position, after three (3) minutes a “Stuck Button” alarm is triggered which suspends insulin delivery (including basal). You may not be able to clear the alarm as the keypad is unresponsive. In the rare situation where this continues for more than ten (10) minutes, the pump will begin to siren.

Once the alarm is triggered and insulin is suspended, you will be unable to program a bolus or resume insulin delivery until the alarm is cleared.

What should I do if this happens to my pump?

If you experience this keypad condition, and want to resolve it immediately to bolus or clear the alarm, remove the battery cap from the pump and then place it back on.

PLEASE NOTE: You should have a fresh new AA battery available in case your pump prompts you to insert a new battery.

What if I have more questions?

If you have other questions or concerns, you can find an FAQ and a copy of this letter at http://www.medtronicdiabetes.com/notice6

You can also always reach the Medtronic 24-Hour Helpline at 1-888-204-7616.

Note: This only applies to MiniMed™ 600 series insulin pumps. The MiniMed™ Paradigm insulin pumps are not affected by this condition.

You can report a concern to the FDA’s MedWatch Adverse Event Reporting program, online at: http://www.fda.gov/safety/medwatch/howtoreport/


Report by telephone: 1-800-FDA-1088/Fax report: 1-800-FDA-0178.

Medtronic considers patient safety and customer satisfaction our primary priorities. We appreciate your time and attention in reading this important notification.

Frequently asked questions


Although any customer safety notification is considered a recall, this is the lowest level and you are not required to return your pump.
No, you do not have to replace your pump unless the removing and replacing the battery cap does not fix the problem. If this does not relieve the pressure and the keypad is not functioning as normal then please call your local HelpLine to troubleshoot and find out what next steps should be taken.
The easiest thing to do if you are not experiencing a “Stuck Button” alarm is to wait for the pump to resolve the issue on its own. However, we realize that you may want to quickly get your pump back to a normal state so the quickest solution is to remove the battery cap and put it back on the pump.

This is a very rare and temporary condition so we do not expect this to occur. However, if you wish to avoid this completely while in flight, you should temporarily remove the battery cap during take-off and landing and only place it back on after your flight has leveled in altitude.

Remember: It is recommended to have extra batteries and a backup therapy particularly when you travel in the unlikely event that your pump is unavailable.

This is a rare situation and we do not expect this to happen in most cases. However, because of the potential therapy interruption and simple solution, we have chosen to make our patients aware of this condition.

Remember: It is recommended to have extra batteries and a backup therapy particularly when you travel in the unlikely event that your pump is unavailable.

The best action for ensuring therapy is not or is minimally interrupted for this situation is to:

Always carry a fresh new AA battery for the pump.

Always carry an HCP prescribed back up therapy in the unlikely event the pump is not available.

Your pump will only stop delivering insulin if a button is stuck in a pressed position for three (3) minutes and a “Stuck Button” alarm is triggered which suspends insulin.

In the case where the keypad buttons are difficult to press down, your insulin delivery will not be interrupted.

No, the p-cap feature on the reservoir allows the insulin reservoir compartment to equalize pressure faster than the rest of the body of the pump. Therefore, the delivery of insulin will continue as usual unless the pump keypad is stuck and alarming.
If removing and replacing the battery cap does not improve the keypad responsiveness, then please call your local HelpLine.
The pump pressure will usually equalize and resolve the issue in less than 30 minutes, however, it may take up to 45 minutes.
It is recommended to have a fresh new battery with you when removing the battery cap in case the pump prompts a battery change once restarted. However, if you place your current battery back into the pump and there is enough charge left in the battery, it will provide power to the pump as usual.

Yes, you may notice the keypad appears depressed when under high external pressure.

The images below may help visualize this:



Normal keypad state:


Keypad in a depressed position:

We are investigating different hardware solutions to solve for this rare situation in a long term manner.
If the pump does not have a battery powering the pump, the pump will alarm for 10 minutes to replace the battery and then it will power down.
Yes. It is important to replace the battery cap immediately to avoid therapy interruption and resume insulin. Once you place the battery cap back on the pump and normal power is restored, any basal patterns scheduled will resume as usual.
If your pump is alarming and you cannot deliver insulin, you may wish to remove the battery cap and check if your current battery may still power the pump. Otherwise, it is best to power down the pump and use your HCP prescribed back-up therapy.