How to turn off the Remote Bolus Feature
At Medtronic, patient safety is core to our mission. As you may be aware, during internal testing last year, we discovered a potential issue on the MiniMed™ 600 series pumps that can result in unauthorized pump access. As a result, a communication was sent in September 2022 to patients and the healthcare providers and education has been provided in multiple forums since.
While we have no reports of this being attempted or having occurred, we are proactively asking you, our educators, to ensure you and your patients on the MiniMed™ 630G and 670G systems are familiar with the actions below:
- Turn off the “Remote Bolus” feature on pump if it is turned on.
Note: the “Remote Bolus” capability is on by default. As a result, the patient should take this action even if the feature has never been used. Turning off this feature will ensure no Remote Bolus is possible. More details on how to do this below. - Avoid pairing devices (for example, the pump and blood glucose meter) in a public place.
To turn off the Remote Bolus feature on the MiniMed™ 630G system:
To turn off the Remote Bolus feature on the MiniMed™ 670G system:
*Patients using the MiniMed™ 670G system in SmartGuard™ Auto Mode, will need to deactivate Auto Mode first before turning off the Remote Bolus feature as it is not available in SmartGuard™ Auto Mode. After turning off the Remote Bolus feature, they can reactivate SmartGuard™ Auto Mode. Step by step instructions for exiting from and returning to SmartGuard™ Auto Mode can be found on the MiniMed™ 670G System User Guide and/or Product Support Page.
Should a patient suspect unauthorized access has occurred or if they experience any adverse events or quality problems with their device, we ask that you encourage them to contact Medtronic Technical Support at 1-800 284-4416. Additional information can also be found at www.medtronic.com/security
Important Safety Information: MiniMed™ 670G System
The Medtronic MiniMed™ 670G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of type 1 diabetes mellitus in persons, seven years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed™ 670G system includes SmartGuard™ technology, which can be programmed to automatically adjust delivery of basal insulin based on Continuous Glucose Monitor sensor glucose values and can suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values. The system requires a prescription. The Guardian™ Sensor (3) glucose values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. A confirmatory finger stick test via the CONTOUR®NEXT LINK 2.4 blood glucose meter is required prior to making adjustments to diabetes therapy. All therapy adjustments should be based on measurements obtained using the CONTOUR®NEXT LINK 2.4 blood glucose meter and not on values provided by the Guardian™ Sensor (3). Always check the pump display to ensure the glucose result shown agrees with the glucose results shown on the CONTOUR®NEXT LINK 2.4 blood glucose meter. Do not calibrate your CGM device or calculate a bolus using a blood glucose meter result taken from an Alternative Site (palm) or from a control solution test. It is not recommended to calibrate your CGM device when sensor or blood glucose values are changing rapidly, e.g., following a meal or physical exercise. If a control solution test is out of range, please note that the result may be transmitted to your pump when in the “Always” send mode.
WARNING: Medtronic performed an evaluation of the MiniMed™ 670G system and determined that it may not be safe for use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore this device should not be used in anyone under the age of 7 years old. This device should also not be used in patients who require less than a total daily insulin dose of 8 units per day because the device requires a minimum of 8 units per day to operate safely.
Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. The safety of the MiniMed™ 670G system has not been studied in pregnant women. For complete details of the system, including product and important safety information such as indications, contraindications, warnings and precautions associated with system and its components, please consult http://www.medtronicdiabetes.com/important-safety-information#minimed-670g and the appropriate user guide at http://www.medtronicdiabetes.com/download-library
Important Safety Information: MiniMed™ 630G System with SmartGuard™ technology
Indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus. MiniMed™ 630G system is approved for ages 14 years or older with Guardian™ Sensor 3 and MiniMed™ 630G system is approved for ages 16 years or older with Enlite™ sensor. Both systems require a prescription. Insulin infusion pumps and associated components of insulin infusion systems 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 of insulin pump therapy. Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. 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. Replace the infusion set every 48–72 hours, or more frequently per your healthcare professional’s instructions. Insertion of a glucose sensor may cause bleeding or irritation at the insertion site. Consult a physician immediately if you experience significant pain or if you suspect that the site is infected. The information provided by CGM systems is intended to supplement, not replace, blood glucose information obtained using a blood glucose meter. A confirmatory fingerstick using a CONTOUR®NEXT LINK 2.4 meter is required prior to making adjustments to diabetes therapy. Always check the pump display when using a CONTOUR®NEXT LINK 2.4 meter, to ensure the glucose result shown agrees with the glucose results shown on the meter. Do not calibrate your CGM device or calculate a bolus using a result taken from an Alternative Site (palm) or a result from a control solution test. If a control solution test is out of range, please note that the result may be transmitted to your pump when in the “Always” send mode. It is not recommended to calibrate your CGM device when sensor or blood glucose values are changing rapidly, e.g., following a meal or physical exercise. The MiniMed™ 630G or MiniMed™ 530G system are not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the Suspend on low alarm and take measures to prevent or treat hypoglycemia themselves. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s healthcare provider.
WARNING: The SmartGuard™ Suspend on low feature will cause the pump to temporarily suspend insulin delivery for two hours when the sensor glucose reaches a set threshold. Under some conditions of use the pump can suspend again, resulting in very limited insulin delivery. Prolonged suspension can increase the risk of serious hyperglycemia, ketosis, and ketoacidosis. Before using the SmartGuard feature, it is important to read the SmartGuard™ feature information in the User Guide and discuss proper use of the feature with your healthcare provider.
See www.medtronicdiabetes.com/importantsafetyinformation and the appropriate user guides for additional important details.