Healthcare professionals are requested to have systems in place to remind their diabetic patients:
to use devices that have been recommended or prescribed for them by their diabetes specialist
not to stop or change their prescribed insulin management regimen without seeking the advice of their diabetes specialist
to contact their diabetes specialist if they are invited by a manufacturer to trial a new device e.g. via social media
Diabetes healthcare professionals
Deadlines for actions
Actions underway: 09 November 2016
Actions complete: 21 December 2016
Examples of insulin delivery systems affected by this alert:
- disposable patch pumps
- reusable ambulatory infusion pumps
- insulin cartridges
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- Diabetes clinics/outpatients
- Diabetes nurse specialists
- Diabetes, directors of
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- General practitioners
- General practice managers
- General practice nurses
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: email@example.com and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2016/020 or 2016/009/029/291/001.
Jenifer Hannon or Roopa Prabhakar, MHRA
Tel: 020 3080 7153 and 020 3080 7293
Email: firstname.lastname@example.org or email@example.com
Dr Camilla Fleetcroft, MHRA
Tel: 020 3080 6097
Reporting adverse incidents in England
Through Yellow Card
Alerts in Northern Ireland are distributed via the NI SABS system
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre,
Department of Health,
Social Services and Public Safety
Tel: 028 9052 3868
Reporting adverse incidents in Northern Ireland
Please report directly to NIAIC using the forms on our website.
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre,
Health Facilities Scotland,
NHS National Services Scotland
Tel: 0131 275 7575
Fax: 0131 314 0722
Reporting adverse incidents in Scotland
NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.
Private facilities providing care to private clients report to the Care Inspectorate and MHRA.
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales)