National Patient Safety Alert. NovoRapid PumpCart in the Roche Accu-Chek Insight insulin pump: risk of insulin leakage causing hyperglycaemia and diabetic ketoacidosis (26 May 2022)

Summary

The MHRA continues to receive serious reports of harm associated with insulin leakage for the NovoRapid PumpCart prefilled insulin cartridge in the Accu-Chek Insight Insulin pump. In some patients, there were serious consequences arising from inadequate supply of insulin, including diabetic ketoacidosis (DKA).

Although the manufacturer Roche Diabetes Care (RDC) has implemented a number of risk minimisation strategies to reduce the incidence of these events, the impact of these is inconclusive and we are taking further action to protect patients.

To protect patient safety, diabetes healthcare professionals should inform patients who use the Accu-Chek Insight of the risk of leakage. Clinical care decisions should be made to ensure patients are moved onto alternative pumps where possible.

Actions

• Identify whether you have any Roche Accu-Chek Insight Insulin pump devices in your organisation, or if you have provided them to patients under your care. Any affected stock should be quarantined.
• Contact users of affected devices and undertake a patient-centred risk assessment (see additional information) to determine suitability to move onto an alternative pump based on individual risk.
• Identify suitable alternative pumps and use local procurement procedures to acquire them.
• Onboard patients to new pumps and ensure an appropriate follow-up period as per standard practice and guidance for initiating pump therapy within your organisation.
• Patients with diabetes can continue to use affected devices if there is a lack of suitable alternative insulin therapy or if this has been deemed necessary after the patient-centred consultation. Any continued use of the affected device at any stage of the implementation of this alert requires a local risk assessment to be completed and documented (see additional information).