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MHRA medical device alert – NovoPen Echo and NovoPen 5 insulin pens (Novo Nordisk)

MDA number: MDA/2017/024

Date issued: 24th August 2017

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert for certain batches of NovoPen Echo and NovoPen 5 insulin pens (Novo Nordisk).

Novo Nordisk had detected that the redesigned cartridge holder for the NovoPen Echo and NovoPen 5 can become weakened if exposed to chemicals in cleaning agents, sunscreen and food grease, and the snaps keeping the cartridge holder in place may crack or break off.

The following advice has been issued, which pharmacy teams are required to action:

  • Identify patients who use NovoPen Echo and NovoPen 5 insulin pens and inform them of the manufacturer’s Field Safety Notice, which lists the 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 the user is able to maintain insulin regime via a suitable device or alternative method.
  • Advise patients that if they have questions or concerns, they can contact their doctor, pharmacist or Novo Nordisk’s Customer Care Line on 0845 600 5055
  • Contact Alloga on 0177 3515 124 to arrange replacements and return any affected stock that the pharmacy has.

 

To view the alert, please visit the MHRA website.

 

Hints & Tips

Useful web links: If you need any helpful links to various PMR based websites, press the Help button and then the Resources option for a list of useful websites.

Active products: Use the active products report to monitor products being used; tag and template them to reduce and deactivate unwanted products or to set as restricted items.

Drug notes: A short note can be added to any dispensed item by pressing CTRL + N and it will be remembered for future reference.