People with diabetes who use NovoPen® Echo® and NovoPen® 5 should check to see if their devices are included in the company-led recall by Novo Nordisk.
The insulin cartridge holder in certain batches may crack or break resulting in an under-delivery of insulin which can lead to high blood glucose (hyperglycaemia) and can have serious health implications.
Novo Nordisk has detected the insulin cartridge holder used in a number of NovoPen® Echo® and NovoPen® 5 batches can be structurally compromised if exposed to certain chemicals, for example household cleaning agents.
People using devices from the affected batches should contact Novo Nordisk to replace the cartridge holder.
John Wilkinson, MHRA’s Director of Medical Devices said:
This is a company-led recall and we are supportive of the proactive approach being taken by Novo Nordisk.
It is important patients do not stop treatment without contacting their diabetes management team. We are asking people using a NovoPen® Echo® and/or NovoPen® 5 from one of the affected batches to contact Novo Nordisk to replace the cartridge holder as some could be damaged or subject to damage in the future.
We continue to encourage people to report any issues involving medical devices to the MHRA via our Yellow Card Scheme.
Dan Howarth, Head of Care at Diabetes UK said:
Ensuring the correct level on insulin is vitally important in the management of diabetes; so it’s important that anyone affected by this recall contact Novo Nordisk to arrange for a replacement cartridge holder.
If they have any concerns about their level of insulin they should consult with their diabetes care team.