Health Canada — Medical Devices · Canada · 2014-04-14 · Type II
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Reported risk: Purpose of this notification is to reinforce important information regarding the safe use of Medtronic insulin pumps. Medtronic has received a small number of reports regarding users who have unintentionally programmed the pump to deliver the maximum bolus amount, including one incident that resulted in severe hypoglycemia. The inadvertent selection and delivery of a bolus amount that exceeds the amount intended by the user can result in hypoglycemia. Medtronic is notifying all Paradigm pump users Healthcare professionals and certified pump trainers of the function of the wrap around scrolling feature and make them aware of the potential for user error.
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