Urgent Medical Device Correction: Medtronic Basal Setting Programing

You are receiving this letter because our records indicate that in the last 6 months, you have either received a new insulin pump or a replacement insulin pump.  We want to remind you that the pump you received was NOT pre-programmed with your basal rates or other verified settings (i.e., bolus wizard settings, sensor settings, etc) which must be set up and saved on our pump prior to use.

Basal insulin is the “background” insulin needed throughout the day to maintain your target glucose values when you are not eating.  Your basal insulin accounts for about half of your daily insulin requirements.  Basal insulin delivery is an important component of your total insulin dose.

If the basal rate settings are intended to be set but not entered at all or if they are entered but not saved prior to pump use, it could result in an under-delivery of basal insulin.  Under-delivery of insulin can potentially cause severe hyperglycemia, which may lead to life-threatening diabetic ketoacidosis (DKA).

Serious injuries have been reported with the use of the MiniMed™ 600 series and MiniMed™ 700 series insulin pumps which may be directly attributed to not setting basal rates.  In addition, one death has been reported, although a review by independent clinical experts did not directly attribute this to not setting basal rates.  If basal rates are not set in the pump when they should be, it could potentially lead to those events as explained above.

For additional information and answers to frequently asked questions, please contact www.medtronicdiabetes.com/basal-setting-programming .

Please contact Medtronic 24-Hour Technical Support at 800-646-4633, option 1 for the following:

• If you encounter any issues with setting basal rates or notice that basal rates are missing.
• If you experience any adverse events or quality problems associated with the use of this product.