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

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

August 24, 2017

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 has 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 Lane on 0845 600 5055; and
  • contact Alloga on 0177 3515 124 to arrange replacements and return any affected stock that the pharmacy has.

Deadline for actions:

Actions underway: 8th September 2017

Actions complete: 25th September 2017

To view the alert please visit the MHRA website.

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