Important safety information for refillable insulin pens NovoPen Echo or NovoPen 5 - Replacing the cartridge holder

Safety warnings | messages in brief | 05/07/2017

NovoPen Echo and NovoPen 5 are used for insulin therapy in people with diabetes. It has been noted that the insulin cartridge holder may tear or break in certain lots of NovoPen Echo and NovoPen 5 insulin pens. Using a pen with a torn/broken cartridge holder may result in a lower insulin dose being delivered than intended. This may result in a rise in blood glucose levels. The cartridge holder should therefore be replaced as a precaution, as some holders may already be damaged or may be damaged if they continue to be used. According to the manufacturer, approximately 20,000 patients in Austria are affected.

Situation in Austria

In Austria, the following medical devices are affected:

NovoPen Echo:

**Table 1.** list of NovoPen Echo batches affected in Austria.
DUG2055	FVG7337-4	DVG1368-5	FVG8132-1
DVG1564-5	FVG8131-6	DVG1566-2	FVG8414-4
DVG1715-1	FVG8997-5	EVG5699-3	FVG8995-4
EVG5946-4	DUG2058	EVG6824-8
Note: The hyphen and the following digit after the lot number are printed on the packaging only.

NovoPen 5:

**Table 2.** list of NovoPen 5 lots affected in Austria.
EVG4360-4	FVG7563-2	EVG2296-2	EVG6821-2
EVG5564-1	FVG7565-1	EVG2296-3	FVG0118-2
FVG7150-2	FVG8531-1	EVG2903-1	FVG0406-2
FVG7336-1	EVG2295-2	EVG2905-1
FVG7562-2	EVG2295-3	EVG6244-3
Note: The hyphen and the following digit after the lot number are only printed on the packaging.

The illustrations above show where you can find the lot number on the NovoPen Echo or NovoPen 5 (unscrew the dose knob until the lot number is visible!).

The red markings in the figures indicate where the batch numbers can be found on the A) NovoPen Echo and B) NovoPen 5. For example: the lot number of the NovoPen Echo is FVG7364. (Image source: Novo Nordisk)

Patients in possession of a NovoPen Echo and/or NovoPen 5 insulin pen with alot number other than the one listed above have no reason for concern and can be confident that the pen is functioning properly. The BASG currently has no reports of malfunctions in this regard from Austria.

Recommendations of the BASG

Recommendations for patients:

The risk of being exposed to high blood glucose levels through the use of an insulin pen of the affected batches is reported to be less than 0.1 percent. This means in only 1 in 1,000 patients will a high blood glucose level result from an actual torn/broken cartridge holder.

The warning symptoms for high blood sugar (hyperglycemia) usually occur gradually and may include: red, dry skin, drowsiness, fatigue, dry mouth, fruity or acetone-smelling breath, frequent urination, thirst, loss of appetite, feeling sick (nausea or vomiting).

You may not notice any physical signs of high blood sugar and may only be able to detect it by measuring your blood sugar.

Measure your blood glucose level as shown by your healthcare professional. Measure more frequently if you experience unexpected signs of high or low blood glucose. If you notice signs of high blood glucose associated with the insulin pen, seek medical advice immediately.

Do not stop the treatment without consulting your doctor first.

To exchange the cartridge holder with the manufacturer, please register with your contact details (name, address, telephone number, e-mail address and number of cartridge holders affected) either via the website of the Austrian subsidiary (www.novonordisk.at) or directly on the international company website of Novo Nordisk(www.novonordisk.com). Alternatively, you can contact Novo Nordisk customer service by phone or e-mail (tel: 0800 24 00 45, e-mail: kundenservice@novonordisk.com) to obtain a replacement for the affected cartridge holder by courier service.

The user manual of the NovoPen Echo or NovoPen 5 describes how to place and use the new cartridge holder on the pen. If you have any further questions or feel unsure, please contact your doctor or pharmacist.