Medical Device Alert: Ambulatory insulin infusion pump. Accu-Chek Spirit manufactured by Roche Diagnostics (MDA/2009/027)

This replaces MDA/2009/024. Action points have been changed.

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/027 or 2008/011/014/291/015

Technical aspects
Nicole Small or Catriona Blake
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3310/3219
Fax: 020 7084 3209

E-mail:
nicole.small@mhra.gsi.gov.uk
catriona.blake@mhra.gsi.gov.uk

Clinical aspects
Jonathan Plumb
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3128
Fax: 020 7084 3111

E-mail: jonathan.plumb@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website http://www.mhra.gov.uk
Further information about CAS can be found at https://www.cas.dh.gov.uk/Home.aspx

This replaces MDA/2009/024. Action points have been changed.

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US

Tel: 02890 523 704
Fax: 02890 523 900

E-mail: NIAIC@dhsspsni.gov.uk

http://www.dhsspsni.gov.uk/index/hea/niaic.htm

This replaces MDA/2009/024. Action points have been changed.

Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

E-mail: iric@shs.csa.scot.nhs.uk

http://www.hfs.scot.nhs.uk/online-services/incident-reporting-and-investigation-centre-iric/

This replaces MDA/2009/024. Action points have been changed.

Enquiries in Wales should be addressed to:
Dr Jane Ludlow
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3505 / 3922

E-mail: Haz-Aic@wales.gsi.gov.uk

This replaces MDA/2009/024. Action points have been changed.

Due to a design fault, the ‘up’ and ‘down’ arrow buttons can fail. If both the buttons fail at the same time, the activation of the bolus function and the adjustment of the preset basal function will be inhibited.

This means that there is a risk that insulin therapy is compromised.

The MHRA has been informed by Roche that, due to a design fault, the operation of the pump's ‘up’ and ‘down’ arrow buttons can fail.

• If both the buttons fail at the same time, the activation of the bolus function and the adjustment of the preset basal function will be inhibited.
• If only one of the buttons fails, a standard bolus rate can still be programmed by using the working button to scroll through the bolus increments, as detailed in the manufacturer's instructions for use.

When the buttons fail, the basal rate infusion will continue at its existing rate.

In the UK, 96 pumps (approximately 3.7%) have exhibited failure of one or more of the buttons.

This replaces MDA/2009/024. Action points have been changed.

• Ensure that patients using the pump are aware of the potential for the ‘up’ and ‘down’ buttons to fail.
• Patients who are concerned should contact the manufacturer for further advice.
• Patients who experience problems with their pump should immediately contact the manufacturer's 24 hour care line to arrange a replacement device.
• A back-up delivery method should be available at all times.
• Report any problems with the pump to the MHRA.

This replaces MDA/2009/024. Action points have been changed.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC) (Headquarters)
• HSC Trusts in Northern Ireland (Chief Executives)
• NHS Boards in Scotland (Chief Executives)
• OFSTED (Directors of Children’s Services)
• Primary care trusts in England (Chief Executives)

Onward distribution Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

Trusts to:
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

• Clinical governance leads
• Diabetes clinics/outpatients
• Diabetes nurse specialists
• Diabetologists
• EBME departments
• Endocrinology units
• Endocrinology, directors of
• Hospital at home units
• Hospital pharmacists
• Medical directors
• Nursing executive directors
• Outpatient clinics
• Paediatricians
• Pharmacists
• Purchasing managers
• Risk managers
• Supplies manager

Care Quality Commission (CQC) (England only) to:
Headquarters for onward distribution as appropriate to:

• Care homes providing nursing care (adults)
• Care homes providing personal care (adults)
• Hospices
• Hospitals in the independent sector
• Independent treatment centres

Primary care trusts to:
CAS liaison officers for onward distribution to all relevant staff including:

• Community children’s nurses
• Community diabetes specialist nurses
• Community hospitals
• Community pharmacists
• District nurses
• General practitioners
• Pharmaceutical advisor
• Practice nurses
• Walk-in centres

OFSTED to:
Directors of children’s services for onward distribution to:

• Educational establishments with beds for children
• Residential special schools

Change of address or removal from address list for Care Quality Commission:
National Contact Centre Care Quality Commission
St Nicholas Building
St Nicholas Street
Newcastle-upon-Tyne
NE1 1NB

Tel: 03000 61 61 61

E-mail: enquiries@cqc.org.uk

This replaces MDA/2009/024. Action points have been changed.

Accu-Chek Pump Careline
Roche Diagnostics Ltd
Chalres Avenue
Burgess Hill
RH15 9RY

Tel: 0800 731 2291
Fax: 0808 100 8060

E-mail: burgesshill.insulinpumps@roche.com