- Identify all users of Accu-Chek Insight insulin pumps.
- Ensure that all patients and carers:
- Receive the manufacturer’s Field Safety Notice (FSN)
- understand the problem detailed in the FSN and follow the advice given by the manufacturer
- use Energizer® Ultimate lithium batteries (1.5V AAA / FR03) provided by the manufacturer and follow the steps described in the handling instructions in the FSN
- Contact Roche if you experience unexpected pump shut down or rapid battery depletion.
- Return the FSN acknowledgment form to Roche as currently the manufacturer hasn’t received enough responses.
Everyone responsible for the use and maintenance of these devices, particularly diabetes care specialists.
Deadlines for actions
Actions underway: 23 May 2017
Actions complete : 6 June 2017
Note that this alert replaces and updates MDA/2015/029 which we published in August 2015.
Roche has provided updated handling instructions and frequency for battery change to every 14 days from the 30 days previously recommended.
Roche Diabetes Care
Accu-Chek Pump Care
Telephone: 0800 731 22 91
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:
- Community diabetes specialist nurses
- Community hospitals
- Diabetes clinics/outpatients
- Diabetes nurse specialists
- Diabetes, directors of
- EBME departments
- Outpatient clinics
- Paediatric diabetes nurse specialists
- Paediatric wards
- Paediatrics departments
- Risk managers
- Supplies managers
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- Community pharmacists
- General practice managers
- General practice nurses
- General practitioners
This Medical Device Alert is being sent to GPs for information only, in circumstances where patients may seek advice about the contents of this notice. GPs need take no further action on receipt of this alert.
Establishments registered with the Care Quality Commission (CQC) (England only)
- Hospitals in the independent sector
- Independent treatment centres
- Private medical practitioners
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: firstname.lastname@example.org and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2017/010 or 2017/003/001/291/005.
Enitan Taiwo and Jenifer Hannon, MHRA
Tel: 020 3080 7122 / 7153
Email: email@example.com or firstname.lastname@example.org
MHRA Devices Clinical Team
Telephone: 020 3080 7124
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
Telephone: 028 9052 3868
Fax: 028 9052 3900
Northern Ireland Adverse Incident Centre (NIAIC)
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
Telephone: 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
Telephone: 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).