- Identify patients who use NovoPen Echo and NovoPen 5 insulin pens and inform them of the manufacturer’s Field Safety Notice (FSN), which lists affected batch numbers.
- Advise patients to contact Novo Nordisk directly on the Customer Care line on 0845 600 5055 or to use the manufacturer’s website to check if their device is affected and request a replacement cartridge holder.
- Ensure user is able to maintain insulin regime via a suitable device or alternative method.
- Discontinue supply of affected devices.
- If patients have any questions or concerns, they should contact their doctor, pharmacist or Novo Nordisk’s Customer Care line on 0845 600 5055.
- All healthcare professionals should contact Alloga on 01773 515124 to arrange replacements and return affected stock.
- Healthcare professionals
- Those involved in purchasing, supplying and using these devices
Deadlines for actions
Actions underway: 8 September 2017
Actions complete: 25 September 2017
Examples of where to find the batch numbers on the NovoPen Echo and NovoPen 5 are included in the document
The list of affected batch numbers is in the FSN.
Problem / background
In July 2014, a redesigned cartridge holder for NovoPen Echo and NovoPen 5 was implemented to improve robustness. However, the redesigned cartridge holder can become weakened if it is exposed to chemicals in cleaning agents, sunscreen and food grease, and the snaps keeping the cartridge holder in place may crack or break off.
There are 3 types of fault that can occur:
- ‘Snap cracked’
- ‘One snap broken off’
- ‘Both snaps broken off’
In April 2016 Novo Nordisk decided to change production back to the original cartridge holder so that in future all products would be produced with the original cartridge holder. This was effective from 1 September 2016.
Novo Nordisk issued an FSN in July 2017 to recall affected cartridge holders.
Dr Avideh Nazeri
Director of Clinical, Medical and Regulatory
Novo Nordisk Ltd
3 City Place
Beehive Ring Road
West Sussex RH6 0PA
Tel: 01293 613 555
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
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Send enquiries about this notice to MHRA, quoting reference number MDA/2017/024 or 2017/007/003/131/001.
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Devices Clinical Team, MHRA
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