Medtronic Updates MiniMed IFU In Australia to Prevent Dosing Errors

July 24, 2015

Medtronic is providing diabetic Australian patients with updated instructions for use for its portable MiniMed 640G insulin pump after identifying the potential for user error.

The action stems from the device’s message alert screen not timing out, potential causing confusion. That confusion could lead to incorrect dosing — the over or under delivery of insulin — and cause a serious adverse event, the Therapeutic Good Administration says.

If users don’t react promptly to an alert from Bolus Wizard function after inputting blood glucose and carbohydrate intake information, they could administer a bolus dose based on levels that are no longer current, the agency adds.

Medtronic is not removing the pump from the market, but has sent notice to users and healthcare professionals with updated and clarified instructions on how to avoid the problem. — Elizabeth Hollis