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

Official notice

21 Mar 2021

Last checked

21 Mar 2021

High riskACCC

An official ACCC notice concerns Enhanced Enlite Sensor (MMT-7008) and Guardian Sensor 3 (MMT- 7020) Glucose Monitoring System. 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 Published 2021-03-21.

What to do now

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.

Recall number

e1bf1804-289e-4aa4-aa5b-ef53d6ce26f1

Official notice

2021-03-21

The hazard

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

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Affected products

Product 1

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.

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

HOME

Classification

Pharmacy and medical products

App estimate

high

Recall details

Recall number

e1bf1804-289e-4aa4-aa5b-ef53d6ce26f1

Classification

Pharmacy and medical products

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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