Drug Safety Alerts

Medtronic Enlite™ Sensor and Guardian™ Sensor 3 Urgent Medical Device Correction

Medtronic issued an Urgent Medical Device Correction for Enlite™ Sensor (MMT-7008) and Guardian™ Sensor 3 (MMT-7020). This Urgent Medical Device Correction was issued to alert patients and prescribers that taking Hydroxyurea, used to treat some cancers and sickle cell anemia, could cause these sensors to present inaccurate sensor glucose (SG) readings.

Hydroxyurea is used to treat certain diseases, such as cancer and sickle cell anemia. Hydroxyurea is also known by other names, such as hydroxycarbamide, Hydrea™*, Droxia™*, and Siklos™*. Hydroxurea use results in higher SG readings compared to blood glucose (BG) readings and may result in the following:

• Hypoglycemia caused by over-administration of insulin

• Inaccurate graphs or missed alarms and alerts

• Delay to or loss of sensor-enabled insulin suspension (sensor-enabled insulin pump use only)

• SG readings in CareLink™ reports being substantially higher than BG readings

Medtronic is notifying patients using Enlite™ Sensor and Guardian™ Sensor 3, advising them:

• Do not use continuous glucose monitoring (CGM) while taking hydroxyurea.

• Only use their BG meter to monitor glucose levels while taking hydroxyurea.

• Consult with their healthcare professional if they are taking hydroxyurea and using a CGM.

• When using an insulin pump system, disable the CGM feature by going to the sensor settings. Refer to the user guide that came with their insulin pump for instructions.

• Always check the label of any medication to confirm with their healthcare professional whether hydroxyurea or hydroxycarbamide is an active ingredient.

CVS Caremark® Response: CVS Caremark® Mail Service Pharmacy will continue to dispense these products.

For more information about this issue, health care providers may call the Medtronic 24-Hour Technical Support line at 1-800-646-4633, option 1 or visit www.medtronicdiabetes.com.