Four batches of an insulin cartridge holder used by diabetics have been recalled after it was found some cleaning agents caused them to crack.
Novo Nordisk A/S has detected that the insulin cartridge holder used in a small number of NovoPen Echo batches may crack or break if exposed to certain chemicals.
Using a device with a cracked or broken cartridge holder could result in the device delivering a smaller dose of insulin than expected, leading to high blood sugar levels although the risk of receiving the wrong dose was one in 1000.
The affected batch numbers as shown on a Novopen Echo carton were EVG3310-6, EVG4252-2, FVG8142-3 and FVG8415-1. Affected batch numbers as shown on the Novopen Echo pen were EVG3310, EVG4252, FVG8412 and FVG8145.
Novo Nordisk urged people with diabetes using a NovoPen Echo from one of the affected batches to replace the cartridge holder because it could be damaged in the future if not changed.
The warning symptoms of high blood sugar levels normally appeared gradually and included flushed, dry skin; feeling sleepy or tired; dry mouth, fruity (acetone) breath; urinating more often, feeling thirsty; losing your appetite and feeling or being sick. You might not experience any physical signs of high blood sugar levels, but only be able to see this in your blood sugar measurements.
If you are in possession of a NovoPen Echo with a batch number which is not mentioned above, or a NovoPen 3 or NovoPen 4 product, there is no reason for concern.
What to do if you are using a NovoPen Echo with one of the above-mentioned batch numbers:
• Do not stop treatment without consulting your doctor.
• Register your contact details (name, address, phone number, email and number of affected cartridge holders) either via www.novonordisk.com.au or at www.novonordisk.com/novopenecho5.html in order to receive a replacement cartridge holder. A replacement should arrive in about seven days.
• You should measure your blood sugar levels as instructed by your health care provider and more frequently if symptoms of too high or too low blood sugar levels develop unexpectedly.
• In the event that you experience symptoms of too high blood sugar levels involving this product, contact your doctor for advice.
• Report any adverse events or complaints to the NovoCare Customer Care Centre, which can be reached at 0800 733 737 or via email at aunrccc@novonordisk.com.