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Medical Device Alert: Insulin infusion sets and reservoirs used with Paradigm ambulatory insulin pumps (manufactured by Medtronic)

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:

  1. 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.
  2. 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.

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