Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its MiniMed Mio Advance [Model Number: MMT-242, MMT-242T, MMT-242600, MMT-247, MMT-247T, MMT-247600]. The affected products in Hong Kong are identified as the following: -
The manufacturer has notified that the soft cannula insulin fill volume recommended in MiniMed Mio Advance infusion set user guides has been updated.
The current MiniMed Mio Advance infusion set user guide recommends that 6 mm and 9 mm soft cannulas be filled with 0.9 units (0.009 ml) of insulin after inserting a new set. The user guide is now being updated to recommend that 6 mm and 9 mm soft cannulas be filled with 0.6 units (0.006 ml) of insulin.
According to the manufacturer, reducing the soft cannula insulin fill volume to 0.6 units (0.006 ml) will reduce the risk of potential hypoglycemic events, particularly among pediatric patients. This is not a product recall and does not affect any other Medtronic MiniMed infusion set brands.
The manufacturer is notifying all affected customers and patients.
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 21 Dec 2018