Urgent Medical Device Correction: Medtronic Basal Setting Programing
Guidance for Operations Leaders & Customer Service Teams
About the Device Correction:
Medtronic is issuing a device correction on the following insulin pumps:
- 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
Medtronic is issuing the device correction because the insulin pumps received by patients were NOT pre-programmed with their basal rates or other verified settings (i.e., bolus wizard settings, sensor settings, etc.), which must be set up and saved on their pump prior to use.
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.
How to Guide Patients:
Patients who contact AdaptHealth subsidiaries with questions must be informed to contact Medtronic’s 24-Hour Support line for this device correction at: 1-800-646-4633, option 1.
Impacted patients will receive written notification of the device correction with instructions to program the settings on the device.
Additional patient support can be accessed via the following links provided by Medtronic:
- Pump Basal Setting Programming Support: www.medtronicdiabetes.com/basal-setting-support
- MiniMed™ 630G User Guides and Manuals: www.medtronicdiabetes.com/630g-user-guide
- MiniMed™ 670G User Guides and Manuals: www.medtronicdiabetes.com/770g-user-guide
- MiniMed™ 770G User Guides and Manuals: www.medtronicdiabetes.com/770g-user-guide
- CareLink™ Personal: www.carelink.minimed.com