Medical device manufacturer, Medtronic, has issued a field safety notice concerning Medtronic insulin pumps. The affected model numbers are MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-722, MMT-554, and MMT-754.
The manufacturer has received a small number of reports regarding users who have accidentally programmed the pump to deliver the maximum bolus amount, including one incident that resulted in severe hypoglycaemia.
According to the manufacturer, when using the Express Bolus button to deliver a bolus, the down arrow will scroll to 0.0 units and stop. However, all insulin delivery programmed through the Main Menu will allow the down arrow button to scroll from 0.0 units to the programmed maximum insulin dose.
The manufacturer advises users that because accidental button pressing errors may occur, it is important that patients always confirm the insulin dose flashing on the display is correct before pressing ACT to start delivery.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 19 March 2014