Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its MiniMed Sure-T infusion sets.
The manufacturer has identified that certain MiniMed Sure-T infusion sets had a slight increase in reports where the steel needle broke during use. In a small number of these reported cases, the needle break led to hospitalization for the management of glucose levels and/or treatment for removal of the needle. Since then, an improvement in the needle manufacturing was implemented, which has reduced the number of reported cases of needle breaks.
According to the manufacturer, if a needle break occurs, insulin delivery is interrupted and the pump will not alarm to notify users. The interruption of insulin delivery can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis. The manufacturer advises users to consult their healthcare professional if they experience a needle break while the infusion set is inserted.
The manufacturer will replace the affected products if needed and advises users to follow the instructions for use carefully if they continue using the affected products.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 11 June 2015