Enlite & Guardian Sensor (2021-03-08)

Date de début :

8 mars 2021

Date d’affichage :

8 avril 2021

Type de communication :

Rappel d'instruments médicaux

Sous-catégorie :

Instruments médicaux

Classification du risque :

Type II

Source :

Santé Canada

Problème :

Instruments médicaux

Public :

Hôpitaux, Professionnels de la santé, Grand public

Numéro d’identification :

RA-75331

Dernière mise à jour:
2021-04-08

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  Raison
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  Produits touchés

Produits Touchés

A. Enlite Sensor

B. GUARDIAN SENSOR (3)

Raison

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.

Produits touchés