The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulator for medical devices and medicines, has released a national patient safety alert for the NovoRapid PumpCart pre-filled insulin cartridge and the Roche Accu-Chek Insight Insulin pump system.
National Patient Safety Alerts are issued to make sure action is taken by healthcare providers to keep patients safe.
This has happened because the MHRA is concerned that these products may contain cracked cartridges, which could result in leaking insulin.
This would mean that people using their pumps would not be getting the insulin that they need reliably.
Patients asked to check for cracks in their insulin cartridges before using them
The MHRA has advised that patients need to check their pre-filled glass insulin cartridges for cracks before they use them.
You should not use a cartridge if it has any cracks. You should also not use a cartridge if it has been dropped, even if you can’t see any cracks.
Make sure to follow the updated handling instructions in the pump user manual at all times, including when changing pre-filled glass insulin cartridges.
What do these pumps do?
These devices release insulin into your body during the day and night. They are comprised of a pump, tube, battery and a pre-filled glass insulin cartridge.
Reports of insulin leakage
There have been reports of cracked cartridges in Roche Accu-Chek Insight insulin pumps. This means that the insulin was able to leak out of its cartridge. Where this happens, patients will not be able to receive all of the insulin that they need.
Leaks have also been reported in cases where no cracks in the cartridge could be seen.
Key Recommendations for people using Roche Accu-Chek Insight insulin pumps
The MHRA has made several important recommendations.
If you’re using Roche Accu-Chek Insight Insulin pumps, you should:
- Check your pump regularly for damages, such as cracks or insulin leakage. If you smell insulin (which has a strong antiseptic chemical smell) there could be a leakage happening.
- Don’t use any cartridge which has been dropped.
- Carefully check your insulin pump each day and before going to bed, to make sure it’s delivering insulin correctly and that there are no leaks.
- Check your blood sugar levels multiple times throughout the day while using your pump. Your device may not alert you if insulin isn’t being delivered correctly and you might not be able to see any leaks happening.
You should also never change the way you deliver your insulin without first consulting your healthcare team.
If you think that there could be any issues with your insulin pump, you should talk to your healthcare team straight away.
Dr June Raine, Chief Executive, Medicines and Healthcare products Regulatory Agency said:
“For many patients with diabetes, insulin pumps are an important method of treatment and provide freedom and flexibility in the day to day management of their condition.
Because of the rare risk of insulin leakage from the Roche Accu-Chek Insight Insulin Pump, patients should check the pre-filled glass insulin cartridge for any cracks prior to usage.
“We would like to reassure patients that risk of leakage remains low when used in accordance with instructions and today’s safety recommendations. Patients should continue to use their insulin pump as recommended whilst they await contact from their healthcare professional regarding an alternative device.”
“If you suspect a problem with your insulin pump, please seek medical advice immediately.”
Finding support
If you are concerned about the MHRA’S advice, please contact your diabetes healthcare team. In addition, our trained Helpline team are there to support you. Please give them a call on 0345 123 2399 or write at helpline@diabetes.org.uk.
