URGENT MEDICAL DEVICE CORRECTION


New notification: Basal setting programming


MiniMed™ 630G: MMT-1715, MMT-1755, MMT-1754
MiniMed™ 670G: MMT-1780, MMT-1781, MMT-1782, MMT-1760, MMT-1761, MMT-1762, MMT-1740, MMT-1741, MMT-1742
MiniMed™ 770G: MMT-1880, MMT-1881, MMT-1882, MMT-1892, MMT-1891, MMT-1890


New Notification: Basal Setting Programming Download

February 2022

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 requirements1. 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). As described in the user guide, when programming basal rate settings, you must scroll down to select “Done” and then select “Save” on the next screen to activate the basal rate settings. If “Save” is not selected, then basal settings will not be set.

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.

ACTIONS REQUIRED
New Users with New Device:

  1. Do not use your pump until you have consulted with your healthcare professional to determine the settings.
  2. Program your settings as described in Steps 5 (c) and (d) below.
  3. Acknowledge the notification as described Step 6 below.

Existing Users: Replacement or Upgrade devices

  1. Verify current basal rate settings
    To check the current basal rate settings in your pump, follow the instructions on the pump user guide for your pump model under “Viewing your basal information” section. The user guides can also be found on our website through the links provided in the appendix below.
  2. Check if the basal rate settings are present on your pump.
    If the basal rate settings are present on your pump:

    • Proceed to step 6 to acknowledge this notification. For future reference, you may also save your settings to CareLink™, or write them down on a paper and keep it securely.

    If the basal rate settings are not present on your pump, please take all the following actions:

    1. Locate the settings for your pump, including basal rate settings, and consult with your healthcare professional to verify they are the most recent settings.
      • If you cannot get in touch with your healthcare professional, but your previous settings were uploaded to CareLink™ in the past 90 days, you may log into your CareLink™ Personal, navigate to “Reports”, then “Select custom range” to choose a week that had the previous pump’s upload, select “DEVICE SETTINGS SNAPSHOT”, and select “Generate reports”. The settings should have a non-zero basal rate.
    2. Program your new or replaced insulin pump with all your verified settings. Refer to the pump user guide for detailed instructions on programming your insulin pump. If you have your settings but require assistance programming your pump, please contact Medtronic 24-Hour Technical Support at 1-800-646-4633, option 1.
    3. As stated in the user guide, during programming the basal settings on your pump, make sure you respond to all pump screens to ensure your basal settings are saved. As shown in the screen sequence below, you must first scroll down to select “Done”, and then select “Save” on the following screen. The settings are successfully saved when the message “Changes saved” is shown on the screen.

      The exact Basal rates shown above are for example only

  3. Acknowledge notification
    Acknowledge that you have read and understood this notification by completing and returning the confirmation form.

Please contact Medtronic 24-Hour Technical Support at 1-800-646-4633, 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 your use of this product.

Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report online: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

As always, we are here to support you. If you have further questions or need assistance, please call the Medtronic 24-Hour Technical Support line at: 1-800-646-4633, option 1.

At Medtronic, patient safety is our top priority, and we are committed to delivering safe and effective therapies. We apologize for any inconvenience this issue may cause you and we appreciate your time and attention in reading this important notification.

Helpful Links

  1. Pump Basal Setting Programming Support - medtronicdiabetes.com/basal-setting-support
  2. MiniMed™ 630G User Guides and Manuals – medtronicdiabetes.com/630g-user-guide
  3. MiniMed™ 670G User Guides and Manuals – medtronicdiabetes.com/670g-user-guide
  4. MiniMed™ 770G User Guides and Manuals – medtronicdiabetes.com/770g-user-guide
  5. CareLink™ Personal – carelink.minimed.com


1 https://www.medtronicdiabetes.com/customer-support/device-settings-and-features/basal-settings/basal-rate

Frequently asked questions


Yes, by definition, this is a recall for correction. A “recall” does not always mean that you stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed, as is the case here.
At Medtronic, customer safety, awareness and customer satisfaction are our top priorities. Medtronic is proactively notifying impacted customers to ensure that they are made aware of the potential safety risks associated with not having saved basal insulin rates programmed into the pump. Medtronic will remind customers of how to ensure these settings are saved in the pump.
No, this notification is not associated with prior urgent recalls issued by Medtronic.
The instructions for how to program basal rates are included in the user guides for the MiniMed™ 600 and MiniMed™ 700 series pumps. However, in April 2021, Medtronic became aware of instances where basal rates were not correctly programmed and/or saved in a new or replacement insulin pump and began researching the issue to determine why this happens and how to help prevent this from happening.
In researching this issue, we identified that it’s most likely during the first months of transitioning to a new or replacement pump that the basal rate settings may not be saved in the pump. Therefore, we are proactively reaching out to customers who received new or replacement pumps over the past six months to ensure they have basal rates programmed.
No, your device does not require replacement due to this issue.
All pumps arrive with factory settings and must be programmed with your basal rates and/or other verified settings (i.e., Bolus WizardTM settings, sensor settings, etc.), which must be set up and saved on your pump prior to use.
Check if the basal rate settings are present on your pump. If the basal rate settings are not present on your pump, follow the instructions as indicated in the notice letter and the user guide.