Medical Device Alert: Blood glucose meters - 5-second CONTOUR® manufactured by Bayer Diabetes Care (MDA/2010/030)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/030 or 2010/003/024/601/002.

Tecnical aspects
Guido Fumagalli or Susan McLellan
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3144 / 3215
Fax: 020 7084 3106

Email: guido.fumagalli@mhra.gsi.gov.uk or susan.mclellan@mhra.gsi.gov.uk

Clinical aspects
Dr Susanne Ludgate
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3123 
Fax: 020 7084 3111 

Email: susanne.ludgate@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website: Reporting adverse incidents involving medical devices.

Further information about CAS can be found on the Central Alerting System website (external link).

Please note that the Alert MDA/2008/059, identified under the first action point was released prior to the national unification of the Medical Device Alert numbering system and therefore was released in Northern Ireland under MDEA(NI)2008-061.

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  

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website (external link).
Further information about SABS can be found on the SABS website (external link).

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

Email: nss.iric@nhs.net

Health Facilities Scotland - Incident Reporting and Investigation Centre (external link).

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3922

Email: Haz-Aic@wales.gsi.gov.uk 

Affected devices may show falsely high readings when testing samples from neonates. Hypoglycaemia may go undiagnosed as a result.

The MHRA issued MDA/2008/059 in July 2008 warning that 5-second CONTOUR® blood glucose meters may show falsely high readings when testing samples from neonates less than 24 hours old. Since then the manufacturer has issued further advice for the use of these devices when testing samples from neonates (Field Safety Notice, March 2010). According to their letter of 18 March 2010, the manufacturer no longer recommends the use of these devices when testing samples from any neonates.Furthermore, they intend to modify the instructions for use to state that ’5-second CONTOUR® is not intended for use in Neonatal Care‘. The manufacturer has informed the MHRA that the updated instructions for use will be available from late July 2010.

• Do not use 5-second CONTOUR® devices for monitoring blood glucose levels in neonatal care.
• Use an alternative method seeking advice from the local hospital laboratory.
• Ensure that the 5-second CONTOUR® devices are correctly identified and not introduced in neonatal care.

Note: the recommendations in this update replace those given in MDA/2008/059.

This MDA has been distributed to:

• NHS trusts in England (chief executives)
• HSC trusts in Northern Ireland (chief executives)
• NHS boards in Scotland (chief executives)
• NHS boards and trusts in Wales (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:

• Biochemists
• Clinical biochemistry departments
• Clinical governance leads
• Clinical pathologists
• Clinical pathology departments
• Clinical pathology directors
• Intensive care medical staff/paediatrics
• Intensive care nursing staff (paediatric)
• Intensive care units (paediatric)
• Intensive care, directors of
• Maternity units
• Medical directors
• Neonatal nurse specialists
• Neonatology departments
• Neonatology directors
• Nursing executive directors
• Nutrition nurses
• Obstetricians
• Obstetrics and gynaecology departments
• Obstetrics and gynaecology directors
• Obstetrics departments
• Obstetrics nurses
• Directors of paediatrics
• Paediatric nurse specialists
• Paediatric surgeons
• Paediatric surgery, directors of
• Paediatric wards
• Phlebotomists
• Point of care testing co-ordinators
• Purchasing managers
• Risk managers
• Special care baby units
• Supplies managers

Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:

• Hospitals in the independent sector
• Laboratories in the independent sector

Melanie Thorp
Bayer Diabetes Care

Tel: 0845 600 6030 (Bayer Diabetes Support)

Email: diabetesUKsupport@bayer.co.uk

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