A Message from Medtronic

Please know that we care about your safety - that's why Medtronic acted quickly to recall "Lot 8" Quick-set infusion sets. We would like to share some background information about this recall, and also describe how clogged vents on an infusion set could affect blood sugar levels.

 

 

The manufacturing process was corrected and Medtronic is instructing patients to stop using "Lot 8" Quick-set infusion sets. Last week, Medtronic sent more than one million infusion sets to customers to ensure therapy continuation. The company is also working closely with distributor partners to provide infusion sets to everyone who needs them.

 

 

Although patients may wonder if their past blood sugar variability is a result of clogged vents, our internal testing shows that the possibility for insulin over or under delivery is limited to the following two scenarios:

 

Scenario 1

A significant over-delivery of insulin caused by a rapid increase in altitude, potentially leading to a severe hypoglycemic event.

 

Scenario 2

The non-delivery of insulin closely following an infusion set change, potentially leading to a hyperglycemic event.

 

Scenario 1 - Over-Delivery of Insulin

 

For a significant hypoglycemic event to occur as a result of clogged vents, a rapid change in air pressure would be necessary. For example, when taking off in an airplane or quickly driving up a mountain, air pressure could build up inside the reservoir compartment and potentially cause over-delivery of insulin. This could result in a severe hypoglycemic event, which may require immediate action or assistance.

 

Since our testing shows that this occurs only with a rapid increase in altitude, this severe low blood sugar event is different than the typical low blood sugars that many people experience as part of their routine diabetes management.

 

Scenario 2 - Non-Delivery of Insulin

 

During priming, clogged vents may prevent the reservoir compartment from equalizing air pressure. As a result, the insulin pump may appear to be properly primed when it is not. Once the infusion set is inserted, this could lead to a period of non-delivery of insulin, which can potentially result in a hyperglycemic event following an infusion set change.

 

Since this occurs closely following an infusion set change, it may be different than the typical high blood sugars that many people experience as part of their routine diabetes management

 

So that we can serve all of our customers during this recall, we will be sending infusion sets at a rate of approximately one box every three weeks - we are doing this to ensure therapy continuation for everyone. We deeply apologize for the inconvenience of this process. Please know that patient safety is our highest priority.

 

Medtronic Diabetes