Gatwick, UK, 5 July 2017 ­– Novo Nordisk A/S has detected that the insulin cartridge holder used in a number of NovoPen® Echo® and NovoPen® 5 batches may crack or break if exposed to certain chemicals, for example household cleaning agents.  NovoPen® Echo® and NovoPen® 5 are used for insulin treatment by people with diabetes.

 

Novo Nordisk urges people with diabetes using a NovoPen® Echo® and/or NovoPen® 5 from one of the affected batches to contact Novo Nordisk in order to replace the cartridge holder as some could be damaged or subject to damage in the future if not changed. The batch numbers of the affected batches are listed below.

Figure 1. The cartridge holder.

 

 

 

 

Using a device with a cracked or broken cartridge holder can result in the device delivering a smaller dose of insulin than expected leading to high blood sugar. The risk of experiencing high blood sugar with the use of a device with an affected cartridge holder is evaluated to be less than 0.1 %, i.e. only 1 in 1000 patients will experience high blood sugar due to an affected cartridge holder.

The warning symptoms of high blood sugar (hyperglycaemia) normally appear gradually and can be: feeling sleepy or tired; dry mouth, urinating more often, feeling thirsty and unintentional weight loss1. You might not experience any physical signs of high blood sugar, but only be able to see it in your blood sugar measurements.

The affected NovoPen® Echo® and NovoPen® 5 batch numbers distributed in the UK are shown below. Please note the batch number can differ on the pen from the box that it comes in.

NovoPen® Echo® NovoPen® 5
Batch number on carton Batch number on pen Batch number on carton Batch number on pen

 

DUG0191 DUG0191 DVG1930-3 DVG1930
DUG0192 DUG0192 DVG2199-2 DVG2199
DUG0193 DUG0193 DVG3018-2 DVG3018
DUG1613 DUG1613 EVG0506-2 EVG0506
DUG1614 DUG1614 EVG0507-2 EVG0507
DUG1615 DUG1615 EVG0615-2 EVG0615
DUG1616 DUG1616 EVG0707-3 EVG0707
DUG1708 DUG1708 EVG0902-2 EVG0902
DUG1709 DUG1709 EVG2293-1 EVG2293
DUG1775 DUG1775 EVG2906-1 EVG2906
DUG1776 DUG1776 EVG2907-2 EVG2907
DUG1777 DUG1777 EVG2910-2 EVG2910
DUG1778 DUG1778 EVG3008-1 EVG3008
DUG2049 DUG2049 EVG3112-2 EVG3112
DUG2053 DUG2053 EVG6245-1 EVG6245
DUG2054 DUG2054 EVG6822-3 EVG6822
DUG2055 DUG2055 FVG7150-1 FVG7150
DUG2055-1 DUG2055 FVG7564-2 FVG7564
DUG2056 DUG2056 FVG7565-2 FVG7565
DUG2058-1 DUG2058 FVG7565-5 FVG7565
DUG2129-1 DUG2129 FVG7566-2 FVG7566
DUG2218-1 DUG2218 FVG7567-2 FVG7567
DUG2219-1 DUG2219 FVG7612-1 FVG7612
DUG2343-1 DUG2343 FVG7613-1 FVG7613
DVG1565-1 DVG1565 FVG7613-2 FVG7613
DVG1566-1 DVG1566 FVG7616-1 FVG7616
DVG1715-4 DVG1715 FVG7617-2 FVG7617
DVG2297-4 DVG2297 FVG8531-2 FVG8531
EVG2298-6 EVG2298 FVG8532-1 FVG8532
EVG2299-6 EVG2299 FVG8654-2 FVG8654
EVG2300-2 EVG2300 FVG8655-1 FVG8655
EVG2908-2 EVG2908 FVG8657-2 FVG8657
EVG2909-1 EVG2909 FVG8658-1 FVG8658
EVG2915-1 EVG2915 FVG8659-1 FVG8659
EVG3011-1 EVG3011
EVG3011-3 EVG3011
EVG3999-2 EVG3999
EVG4253-3 EVG4253
EVG5697-1 EVG5697
EVG5698-2 EVG5698
EVG5946-8 EVG5946
EVG5962-1 EVG5962
EVG5963-3 EVG5963
EVG6823-2 EVG6823
FVG7337-5 FVG7337
FVG7364-1 FVG7364
FVG7457-1 FVG7457
FVG8212-3 FVG8212
FVG8217-1 FVG8217
FVG8218-1 FVG8218
FVG8995-1 FVG8995
FVG8997-4 FVG8997
FVG8998-1 FVG8998

Table 1. List of affected NovoPen® Echo® and NovoPen® 5 batches in the UK.

 

You can find the batch numbers printed on NovoPen® Echo® and NovoPen® 5 pens (Figure 2) and box (Figure 3) as indicated below.

A.

B.

Figure 2. Red squares show where the batch number is located on (A) NovoPen® Echo® and (B) NovoPen® 5. Please note the pen will need to be dialled up in order to see the batch numbers.  The NovoPen® Echo® can be red or blue in colour, whereas NovoPen® 5 can be blue or grey.

 

Figure 3. Red square shows where the batch number is located on the box.

 

If patients are in possession of a NovoPen® Echo® and/or a NovoPen® 5 device with a batch number which is not mentioned above, there is no reason for concern and they can be confident that the pen will work as intended.

Advice for patients using a NovoPen® Echo® and/or NovoPen® 5 with one of the affected batch numbers:

  • Do not stop treatment without consulting your doctor.
  • Be attentive to your blood sugar levels by checking them regularly and looking for symptoms of hyperglycaemia. If you note these symptoms, measure your blood sugar levels as instructed by your health care provider and take appropriate action.
  • In the event that you experience symptoms of too high blood sugar involving this product, contact your doctor for advice.
  • To request a replacement cartridge holder, register your contact details (name, address, phone number, email and number of affected cartridge holders) either at the local Novo Nordisk website www.novonordisk.co.uk  or contact the Novo Nordisk Customer Care line on  0845 600 5055. Novo Nordisk will extend opening hours of the Customer Care line to include weekends to support patients. Opening hours will be 8am-8pm Mon-Fri and 8am-4pm Sat-Sun.
  • You will receive an unaffected cartridge holder for your NovoPen® Echo® and/or NovoPen® 5 within 7 days. Upon receipt, you should attach the new cartridge holder and use as stated in the Instructions For Use.
  • Report any adverse events or complaints (including a damaged cartridge holder) to Novo Nordisk’s Customer Care line on 0845 600 5055.

 

Dr Avideh Nazeri, Director of Clinical, Medical and Regulatory for Novo Nordisk UK and Ireland said, “Novo Nordisk is committed to delivering high-quality products and sincerely apologises for this unfortunate situation and the concerns and inconvenience it may cause patients and health care professionals. We are working closely with the MHRA and UK patient groups to ensure patient safety and minimise the disruption this situation causes.”

If patients have any questions or concerns, please contact your doctor, pharmacist or Novo Nordisk’s Customer Care line on 0845 600 5055. Novo Nordisk will extend opening hours of the Customer Care line to include weekends to support patients. Opening hours will be Mon-Fri 8-8 and Sat-Sun 8-4.

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Globally headquartered in Denmark, and at Gatwick in the UK, Novo Nordisk employs approximately 42,000 people in 77 countries and markets its products in more than 165 countries. For more information, visit novonordisk.co.uk.

Further information

www.novonordisk.co.uk

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