Paradigm ambulatory insulin infusion pumps - risk of hypoglycaemia

(Medtronic) Risk due to incorrect selection and delivery of bolus amount. (MDA/2014/019)

CAS deadlines

Action underway: 12 June 2014, action complete: 26 June 2014

Note: These deadlines are for staff and patients to be aware of the problem and the advice as recommended by the manufacturer in the FSN.

Device

Paradigm ambulatory insulin infusion pumps.

Manufactured by Medtronic.

Models: MMT- 511, 512, 712, 712E, 515, 715, 522, 522K, 722, 722K, 523, 523K, 723, 723K, 554, and 754.

Paradigm ambulatory insulin infusion pump

Problem

Risk of hypoglycaemia due to incorrect selection and delivery of bolus amount.

Medtronic has received reports of users accidentally programming the pump to deliver the maximum bolus amount.

Medical Device Alert Paradigm ambulatory insulin infusion pumps manufactured by Medtronic

Action

Identify affected pumps.

Ensure that all staff and patients receive the relevant copy of Medtronic’s Field Safety Notice (FSN) dated March 2014 and follow the recommendations.

In particular:

  1. When programming insulin doses through the ‘Main Menu’, be aware that scrolling down allows the dose displayed on the screen to go from 0.0 units to the maximum programmed insulin dose.
  2. Always confirm that the insulin dose flashing on the display screen is correct before starting delivery.
  3. Make sure the ‘Max Bolus’ and ‘Max Basal’ settings are programmed according to individual insulin needs as determined by the healthcare professional.

Action by

  • All those responsible for the use, service and maintenance of these devices
  • diabetes departments.

Distribution

This MDA has been sent to

  • Care Quality Commission (CQC) (headquarters) for information
  • Clinical commissioning groups (CCGs)
  • HSC trusts in Northern Ireland (chief executives)
  • Local authorities in Scotland (equipment co-ordinators)
  • NHS boards and trusts in Wales (chief executives)
  • NHS boards in Scotland (equipment co-ordinators)
  • NHS England area teams
  • NHS trusts in England (chief executives)

Onward distribution

Please bring this notice to the attention of relevant employees in your establishment.

Below is a suggested list of recipients.

Trusts

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

  • Clinical governance leads
  • Community diabetes specialist nurses
  • Community hospitals
  • Diabetes clinics/outpatients
  • Diabetes nurse specialists
  • Diabetes, directors of
  • Diabetologists
  • EBME departments
  • Equipment stores
  • Medical directors
  • Medical libraries
  • Nursing executive directors
  • Outpatient clinics
  • Paediatric diabetes nurse specialists
  • Paediatric nurse specialists
  • Paediatricians
  • 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)

This alert should be read by:

  • Clinics
  • 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: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Manufacturer contact

Lezlie Bridge
Regulatory Affairs Manager, UK & Ireland
Medtronic Limited
Building 9
Croxley Green Business Park
Watford
WD18 8WW
Tel:    01923 212 213
Fax:  01923 225 273

Email: lezlie.j.bridge@medtronic.com

Feedback

If you have any comments or feedback on this Medical Device Alert please email us at: dts@mhra.gsi.gov.uk

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2014/019 or 2014/003/018/081/002.

Technical aspects

Enitan Taiwo or Elke Kerwick
Medicines & Healthcare Products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel:    020 3080 7122 / 6826
Fax:  020 8754 3965

Email: enitan.taiwo@mhra.gsi.gov.uk or elke.kerwick@mhra.gsi.gov.uk

Clinical aspects

Mark Grumbridge
Medicines & Healthcare Products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel:    020 3080 7128
Fax:  020 8754 3965

Email: mark.grumbridge@mhra.gsi.gov.uk

Please report via our website: Reporting adverse incidents involving medical devices
Further information about CAS can be found on the CAS website 

Northern Ireland

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
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald BT4 3SQ
Tel:    02890 523 704
Fax:  02890 523 900

Email: NIAIC@dhsspsni.gov.uk

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

How to report adverse incidents in Northern Ireland

Please report directly to NIAIC, further information can be found on the NIAIC website 
Further information about SABS can be found on the SABS website 

Scotland

All requests regarding return, replacement or modification of the devices mentioned in this alert should be directed to the relevant supplier or manufacturer.

Other enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh EH12 9EB
Tel:    0131 275 7575
Fax:  0131 314 0722

Email:    nss.iric@nhs.net

Incident Reporting and Investigation Centre 

Wales

Enquiries in Wales should be addressed to:

Improving Patient Safety Team
Medical Directorate
Welsh Government
Cathays Park
Cardiff CF10 3NQ

Email:    improvingpatientsafety@wales.gsi.gov.uk

Download documents

Medical Device Alert: Paradigm ambulatory insulin infusion pumps manufactured by Medtronic (MDA/2014/019) (161Kb)

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