NovoPen Echo insulin injection pen

Consumers and health professionals are advised that Novo Nordisk, in consultation with the TGA, is recalling six batches of NovoPen Echo insulin injection pens after detecting that there is a risk that the insulin cartridge holder component may crack or break if exposed to chemicals in certain cleaning agents.

NovoPen Echo insulin injection pens are used for insulin treatment by people with diabetes.

Using a NovoPen Echo insulin cartridge holder that is cracked or broken could result in the device delivering a smaller dose of insulin than expected, which can lead to serious health consequences including hyperglycaemia (high blood sugar levels).

Please note that there are no reported problems with the insulin being administered by these devices and that cracking and breaking of the cartridge holder component should not occur if the device is cleaned in accordance with the instructions in the User Guide. The risk of patients experiencing problems as a result of this issue is considered extremely low.

The affected batch numbers are:

People with NovoPen Echo insulin injection pens from an affected batch are invited to contact Novo Nordisk to arrange to receive a replacement cartridge holder.

Information for consumers

If you or someone you provide care for uses NovoPen Echo insulin injection pens, check the batch numbers on any devices you have to see if they are affected by this recall.

If you have a device from an affected batch, register your details at Novo Nordisk Australia or Important safety information regarding NovoPen® Echo® and NovoPen® 5 to arrange to receive a replacement NovoPen Echo insulin cartridge holder for each of your affected devices.

Do not stop insulin treatment without consulting with your health professional.

Once you receive a replacement cartridge holder, if your injection pen is not currently loaded with an insulin cartridge, stop using it and replace the cartridge holder in accordance with the User Guide as soon as possible.

If the device is currently loaded with an insulin cartridge, replace the cartridge holder in accordance with the User Guide the next time you load a new insulin cartridge.

Be aware of the signs and symptoms of hyperglycaemia. Symptoms normally come on gradually and can include:

• feeling flushed
• dry skin
• feeling sleepy or tired
• dry mouth
• ‘fruity’ breath
• urinating more often
• feeling thirsty
• losing your appetite
• nausea/vomiting.

You might not experience any physical signs of high blood sugar levels and only be able to detect it in your blood sugar measurements.

If you experience any signs or symptoms of hyperglycaemia while using a NovoPen Echo insulin injection pen, measure your blood sugar levels as instructed by your health professional and take appropriate action. Contact your health professional for further advice.

Please note that NovoPen Echo insulin cartridge holders should always be cleaned in accordance with the instructions in the User Guide. Only a water-dampened cloth should be used to clean your device. Bleaching agents such as chlorine, iodine and alcohol should not be used when cleaning NovoPen Echo insulin cartridge holders.

If you have any questions or concerns about this issue, speak to your diabetes nurse educator or other health professional.

Information for health professionals

NovoNordisk has written to health professionals who supply NovoPen Echo insulin injection pens to provide further information about this issue, including details of the recall procedure.

If you have any unused stock of NovoPen Echo insulin injection pens, check the batch numbers to see if they are affected by this recall. Quarantine any devices from the affected batches.

Please contact any patients to whom you have supplied NovoPen Echo insulin injection pens since July 2014 and advise them of this issue.

Additionally, consider reiterating to patients that NovoPen Echo insulin cartridge holders should always be cleaned in accordance with the instructions in the User Guide.

If you have any questions or concerns about this issue, contact NovoNordisk on 1800 668 626.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA’s monitoring of these products. For more information, see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.