Accu-Chek® Insight insulin pump system, manufactured by Roche Diabetes Care – risk of inappropriate treatment

Risk of a hypoglycaemic event if users misinterpret maintenance message ‘M-83 pump not able to complete task’. Users are advised to check pump history before re-initiating a programmed task (e.g. bolus delivery) MDA/2016/005.

Action

  • Identify users of the Accu-Chek® Insight insulin pump system.
  • Ensure that all patients and users receive the manufacturer’s Field Safety Notice FSN and that they understand the problem and the advice given by the manufacturer.
  • Include a copy of the FSN with the Accu-Chek® Insight insulin pump system user manual. The manufacturer will update the manual soon.
  • Return FSN acknowledgment form to Roche.

Action by

All healthcare workers, carers and patients who use these devices. Deadlines for actions.

Deadlines for actions

Actions underway: 02 June 2016

Actions complete: 27 June 2016

Problem / background

The system includes the insulin pump and the diabetes manager. When the diabetes manager displays maintenance message ‘M83 Pump not able to complete task’ there is a risk that users may repeat the programmed task. For example, if the task is to deliver a bolus, and this message is displayed, users may request the task to be repeated, resulting in two bolus doses. Users are instructed to check the pump’s history as this will indicate whether the programmed task has been completed. Roche issued an FSN in March 2016 but has not received enough acknowledgments to confirm that healthcare professionals and users have received and acted on the instructions.

Manufacturer contacts

Roche Diabetes Care Accu-Chek Pump Care Line


Telephone: 0800 731 22 91

Email: burgesshill.insulinpumps@roche.com

Distribution

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
  • Diabetologists
  • EBME departments
  • Equipment stores
  • Outpatient clinics
  • Paediatric diabetes nurse specialists
  • Pharmacists
  • Risk managers
  • Supplies managers

NHS England area teams

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

  • Community pharmacists
  • General practitioners

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)

  • Clinics
  • Hospitals in the independent sector
  • Independent treatment centres
  • Private medical practitioners

Enquiries

England

Send enquiries about this notice to MHRA, quoting reference number MDA/2016/005 or 2016/003/003/701/016.

Technical aspects

Jillan Hussein or Jenifer Hannon, MHRA

Tel: 020 3080 7148 / 7153

Email: jillan.hussein@mhra.gsi.gov.uk or jenifer.hannon@mhra.gsi.gov.ukk

Clinical aspects

Mark Grumbridge, MHRA

Tel: 020 3080 7128 Email: mark.grumbridge@mhra.gsi.gov.uk

Reporting adverse incidents in England

Through Yellow Card

Northern Ireland

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, CMO Group,
Department of Health, Social Services and Public Safety

Tel: 028 9052 3868

Fax: 028 9052 3900

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC)

Please report directly to NIAIC using the forms on our website.

Scotland

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

Email: nss.iric@nhs.net

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.

Wales

Enquiries in Wales should be addressed to:

Healthcare Quality Division,
Welsh Government

Tel: 02920 823 624 / 02920 825 510

Email: Haz-Aic@wales.gsi.gov.uk

Reporting adverse incidents in Wales

Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).

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Accu-Chek® Insight insulin pump system, manufactured by Roche Diabetes Care – risk of inappropriate treatment

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