Enlite & Guardian Sensor (2021-03-08)

Starting date:

March 8, 2021

Posting date:

April 8, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Hospitals, Healthcare Professionals, General Public

Identification number:

RA-75331

Last updated:
2021-04-08

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  Reason
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  Affected products

Affected Products 

A. Enlite Sensor

B. GUARDIAN SENSOR (3)

Reason

Medtronic is notifying all customers who may be using an Enhanced Enlite Sensor or a Guardian Sensor (3) in a Continuous Glucose Monitoring (CGM) system or in a sensor-enabled pump system that, if they are actively taking a medication that lists Hydroxyurea as its main or one of its main ingredients, their sensor could present inaccurately elevated Sensor Glucose (SG) readings. Hydroxyurea 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.

Affected products