The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued the following alert regarding insulin infusion sets and reservoirs used with Paradigm ambulatory insulin pumps (manufactured by Medtronic):
There is a risk of under- or over-delivery of insulin, which may lead to hypoglycaemia or hyperglycaemia.
The root causes are:
- Spillage from the insulin reservoir may block connector vents, preventing correct priming of the pump. Medtronic have issued advice on the correct technique for filling the reservoir.
- The insulin reservoir may leak, due to a manufacturing defect, which may result in under-delivery of insulin and failure of the pump’s occlusion alarm. Medtronic have initiated a recall of affected reservoirs.
If you are concerned that you may be affected by this alert, please contact your healthcare team, or call Medtronic on 01923 212213.