Urgent Field Safety Notification


MiniMed Pro-set infusion set


Download important safety information for the MiniMed Pro-set infusion set 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


We understand that communications like this can be concerning. Your safety is our number one priority, so it is important for us to keep you informed of potential issues with our products. If you still have any unused MiniMed Pro-set infusion sets, you have the choice to either continue to use them or replace them for free with another Medtronic Infusion set. If you choose to continue using the MiniMed Pro-set infusion set, please be sure to do the following:

  • Review the online learning instruction: MedtronicDiabetes.com/infusion-set-support
  • Consider using the MiniMed® Quick-serter® insertion device
  • Follow the instructions for use provided with the product
  • Continue monitoring your blood sugar levels frequently

To replace your MiniMed Pro-set infusion sets:

  • Use the online form at http://www.medtronicdiabetes.com/notice5 (fastest method)

OR

  • Call Medtronic at 866.222.7304
Medtronic continually evaluates feedback we receive from customers through the 24-hour helpline and other channels about situations they encounter with our products. As soon as we saw that there was a higher than expected rate of complaints and user difficulties around kinked cannulas and elevated blood glucose levels, we stopped product shipments and identified next steps—which included notifying all MiniMed Pro-set users.
That depends on your insurance coverage. Please call us at 866.222.7304.

If you still have any unused MiniMed Pro-set infusion sets, you have the choice to either continue to use them or replace them for free with another Medtronic Infusion set.

If you choose to continue using the MiniMed Pro-set infusion set, please be sure to do the following:

  • Review the online learning instruction: MedtronicDiabetes.com/infusion-set-support
  • Consider using the MiniMed® Quick-serter® insertion device
  • Follow the instructions for use provided with the product
  • Continue monitoring your blood sugar levels frequently

To replace your MiniMed Pro-set infusion sets:

  • Use the online form at http://www.medtronicdiabetes.com/notice5 (fastest method)

OR

  • Call Medtronic at 866.222.7304