Luxembourg's Ministry of Health and Social Security has reported that a safety notice regarding certain models of Medtronic MiniMed insulin pumps has been issued by Medtronic USA, represented in Europe by Medtronic B.V. in the Netherlands; this measure aims to prevent possible health risks related to the use of these devices.
Identified problem
Medtronic has observed a premature reduction in battery life on certain models of MiniMed insulin pumps. This malfunction may cause an unexpected stoppage of insulin delivery, particularly if the pump has been subjected to impacts, shocks or falls, which could damage its internal components.
Potential Health Risk
A prolonged interruption of insulin delivery may expose patients to the risk of serious complications, such as hyperglycemia (blood glucose >400 mg/dL or >22.2 mmol/L) and diabetic ketoacidosis (DKA), which may require immediate medical attention.
Actions taken by Medtronic
Medtronic plans to notify affected users directly in Luxembourg, where 861 products have been distributed. A Field Safety Notice (FSN FA1435) will also be sent to provide details and action to be taken. Users are advised to follow the instructions provided carefully.
Further information is available on Sante.lu.
