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Originator: National Patient Safety Alert - MHRA

Issue date: 26-May-2022 12:51:30

This alert has been issued to:
  • Care Trusts
  • Mental Health Trusts
  • Specialists Trusts
  • Learning Disabilities Trusts
  • Mental Health & Social Care Trusts
  • Ambulance Trusts
  • Mental Health & Learning Disabilities Trusts
  • Acute Trusts
  • Community Trusts

  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • NHS Regional Offices
  • Special Health Authorities
  • GP - Locum
  • NHS 111 and Out of hours providers
  • GP Practices
  • Community Pharmacy
  • Primary Care Networks
  • GP Practices 1

Action category: Action

Title: NovoRapid PumpCart in the Roche Accu-Chek Inight insulin pump: risk of insulin leakage causing hyperglycaemia and diabetic ketoacidosis

Broadcast content:

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.

Additional information: NHS England and NHS Improvement Regional Offices: please cascade this alert to Community pharmacy

Alert reference: NatPSA/2022/004/MHRA

Action underway deadline: 30-May-2022

Action complete deadline: 26-Nov-2022


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency