Enhanced Enlite Sensor (MMT-7008) and Guardian Sensor 3 (MMT- 7020) Glucose Monitoring System
Published 21 March 2021
Product
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.
Why it was recalled
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.
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
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.