Here at Medtronic Diabetes, we’re committed to keeping customers like you informed about issues and solutions concerning our products and services. Your safety is absolutely our top priority, which is why I’m writing today to let you know about a potential safety issue and provide you with information on how you can avoid it.While changing a Medtronic Paradigm infusion set, if insulin, or any liquid, gets on the inside of the tubing connector on Paradigm infusion sets, it can temporarily block the vents that allow the pump to properly prime. This can potentially result in the delivery of too much or too little insulin, which may cause hypoglycemia or hyperglycemia.The potential for temporary blocking of the infusion set vents can be avoided by not allowing liquid to make contact with the inside of the tubing connector and by following the recommended reservoir fill procedure, provided to you when you received your pump and on our Website
When the reservoir fill process and priming procedures are followed according to the instructions, the Paradigm reservoirs and infusion sets in the Paradigm pumps should work as intended. Because your safety is our number one priority, we are communicating to you – about both the potential issue and how to avoid it – both here at The LOOP and in a letter mailed to your home this week. We’ve also sent a letter to your healthcare professional about this potential issue.
As always, we appreciate your trust in us and are committed to supporting you in your diabetes management. You can find more information, including a downloadable copy of the letter you’ll receive this week and answers to a few frequently asked questions, here www.medtronicdiabetes.com/support/product-updates. Should you have any additional questions, please don’t hesitate to contact us at 1.888.204.7616.
IMPORTANT SAFETY INFORMATION
– Medtronic Diabetes insulin infusion pumps, continuous glucose monitoring systems and associated components are limited to sale by or on the order of a physician and should only be used under the direction of a healthcare professional familiar with the risks associated with the use of these systems.
– Successful operation of the insulin infusion pumps and/or continuous glucose monitoring systems requires adequate vision and hearing to recognize alerts and alarms.
Medtronic Diabetes Insulin Infusion Pumps
– Insulin pump therapy is not recommended for individuals who are unable or unwilling to perform a minimum of four blood glucose tests per day.
– Insulin pumps use rapid-acting insulin. If your insulin delivery is interrupted for any reason, you must be prepared to replace the missed insulin immediately.
For more information, please visit MedtronicDiabetes.com/isi.
Tags: insulin pump