Roche Accu-Chek Insight insulin pump with NovoRapid PumpCart insulin cartridges: alert following cases of insulin leakage

A National Patient Safety Alert was issued in June 2022 by the Medicines and Healthcare products Regulatory Agency (MHRA). This followed serious reports of harm associated with insulin leakage during use of the Accu-Chek Insight Insulin pump with NovoRapid PumpCart prefilled insulin cartridges. Patients should be moved on to alternative insulin pumps where possible. It says:

Safety issue from the MHRA
The Roche Accu-Chek Insight insulin pump is a medical device used by insulin-dependent patients with diabetes to deliver insulin. The Accu-Chek Insight pump is used in combination with NovoRapid PumpCart cartridges, which contain insulin (as insulin aspart) in a glass cartridge.

We have received reports of patient harm associated with leakage and over the past 3 years we have kept this safety concern under close review. In some of the reported leakage incidents, the cartridges were found to be cracked and provided an inadequate supply of insulin to patients. However, leakages also occurred in cases where no cracks in the cartridge were visible.

In some patients, serious consequences resulted from an inadequate supply of insulin. We received 25 serious cases in both 2020 and 2021 (including cases where a patient required urgent medical treatment or hospitalisation) in association with an insulin leakage event in UK patients, including 18 cases and 17 cases respectively of diabetic ketoacidosis.

Despite actions from the manufacturer to reduce the incidence of these events, we continue to receive reports of insulin leakage and we have taken further action to protect patients.

Advice for patients and carers:
The MHRA has taken action following cases in which insulin has leaked from the glass cartridge in the Accu-Chek Insight insulin pump – some cases were associated with severely high blood sugar and diabetic ketoacidosis. Your healthcare professional team has been asked to discuss with you changing to another insulin pump where possible.

While you continue to use the Accu-Chek Insight Insulin pump:

• check the pump and cartridge regularly for damages, for example cracks or leakage. If you smell insulin (a strong antiseptic chemical smell) this could also indicate a leakage.
• follow the advice in the latest customer notice to replace previous designs for pump adaptors and tubing.
• do not use the cartridge if cracks or leakage are seen or if the cartridge was dropped. Follow the instructions of your Accu-Chek Insight user manual for replacing a cartridge and for cleaning the cartridge compartment in the insulin pump.
• during the day and before going to sleep please carefully check that your insulin pump is delivering insulin and there are no leakages.
• never change treatment delivery methods without first consulting a relevant healthcare professional.
• failure of insulin delivery due to leakage may not result in an alert notification from the insulin pump and cracks and leakages may not always be visible. You should check blood glucose levels multiple times throughout your day while using pumps.
• tell your healthcare professional immediately if you suspect a problem with your insulin delivery.

Roche Diabetes Care ceased marketing the Accu-Chek Insight pump in the UK at the end of 2021 and new patients will not be offered the pump. Therefore, all existing Accu-Chek Insight pump users will need to be transferred to an alternative pump at the end of their pump warranty, irrespective of the outcome of their risk assessment.