Enhanced Enlite Sensor (MMT-7008) and Guardian Sensor 3 (MMT- 7020) Glucose Monitoring System

The sensors may show falsely elevated sensor glucose readings for users who are taking hydroxyurea, an anti-neoplastic drug, used primarily in chemotherapy. Incorrect glucose readings may result in incorrect diabetes treatment decisions.

Reason / Defects: The sensors may show falsely elevated sensor glucose readings for users who are taking hydroxyurea, an anti-neoplastic drug, used primarily in chemotherapy. Incorrect glucose readings may result in incorrect diabetes treatment decisions. Hazards: If incorrect information is used to make treatment decisions, this could lead to an incorrect dose of insulin. Hydroxurea use results in higher sensor glucose readings compared to blood glucose readings and may result in the following: · Inaccurate graphs or missed alarms and alerts · Delay to or loss of sensor-enabled insulin suspension (sensor-enabled insulin pump use only) · Sensor glucose readings in CareLink reports being substantially higher than blood glucose readings What to do: Medtronic will contact affected users in writing. Medtronic are advising patients: · Do not use continuous glucose monitoring while taking hydroxyurea. · Only use the blood glucose meter to monitor glucose levels while taking hydroxyurea. · Consult with a healthcare professional if users are taking hydroxyurea and using continuous glucose monitoring. · When using an insulin pump system, disable the continuous glucose monitoring feature by going to the sensor settings. Refer to the user guide that came with the insulin pump for instructions. · Always check the label of any medication to confirm with a healthcare professional whether hydroxyurea or hydroxycarbamide is an active ingredient. For further information, contact Medtronic Customer Service by phone on 1800 777 808.

Enhanced Enlite Sensor (MMT-7008) and Guardian Sensor 3 (MMT-7020) ARTGs 313740 - Medtronic Australasia Pty Ltd - Enlite Glucose Sensor - Subcutaneous glucose sensor 313741 - Medtronic Australasia Pty Ltd - Guardian Sensor (3) - Subcutaneous glucose sensor Enhanced Enlite Sensor (MMT-7008) and Guardian Sensor 3 (MMT-7020) are primarily used for monitoring glucose levels for the management of diabetes mellitus.