GlucoMen LX Sensor test strips used to monitor blood glucose levels - risk of over-estimation

Distributed by Menarini Diagnostics UK - if test strips have been exposed to high humidity, the results can be falsely high (MDA/2015/039)


  • Identify patients who use the GlucoMen LX PLUS meter
  • Ensure that patients, or their carers, are able to use this device and that they are aware of what to do if a result is out of their normal range
  • To avoid false high readings, advise them to follow the instructions for use, which includes making sure that the strips are not exposed to high environmental humidity for a prolonged period of time. Users should always:
    • close the vial immediately after each use
    • store the test strips in their original vial
    • write the discard date on the vial label, which should be 9 months after the date of first opening the vial itself

Actions by

  • Healthcare personnel managing patients who use these devices

Deadlines for actions

Actions underway: 29 December 2015, actions complete: 28 January 2016

Device details

GlucoMen LX Sensor test strips

GlucoMen LX Sensor test strips

GlucoMen LX PLUS meter

InlineAttachment:GlucoMen LX PLUS meter 2


The manufacturer knows of cases where users obtained a falsely high blood glucose reading because of inappropriate storage of test strips.

The manufacturer issued a field safety notice (FSN) in November 2015 stating that prolonged exposure of strips to high humidity may lead to incorrect (high) blood glucose readings.

Manufacturer contacts


Richard King
Menarini Diagnostics UK
Wharfedale Road Winnersh
RG41 5RA

Telephone: 0118 944 4100



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:

  • Ambulance services directors
  • ambulance staff
  • chief pharmacists
  • clinical governance leads
  • community children’s nurses
  • community diabetes specialist nurses
  • community nurses
  • diabetes clinics/outpatients
  • diabetes nurse specialists
  • diabetes, directors of
  • district nurses
  • health visitors
  • hospital at home units
  • hospital pharmacies
  • hospital pharmacists
  • medical directors
  • minor injury units
  • nhs walk-in centres
  • paediatrics departments
  • paramedics
  • pharmaceutical advisors
  • pharmacists
  • purchasing managers
  • risk managers
  • school nurses
  • supplies managers
  • walk-in centres

Public Health England

Directors for onward distribution to:

  • risk manager
  • safety officers

NHS England area teams

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

  • general practitioner

Social services

Liaison officers for onward distribution to all relevant staff including:

  • care at home staff
  • care management team managers
  • children’s disability services
  • community care staff

Independent distribution

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

  • adult placement
  • care homes providing nursing care (adults)
  • care homes providing personal care (adults)
  • clinics
  • domiciliary care providers
  • further education colleges registered as care homes
  • hospices
  • hospitals in the independent sector
  • independent treatment centres
  • nursing agencies
  • private medical practitioners

Establishments registered with OFSTED

  • children’s services
  • educational establishments with beds for children
  • residential special schools

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: and requesting this facility.



Send enquiries about this notice to MHRA, quoting reference number MDA/2015/038 or 2015/011/010/131/003.

Technical aspects

Guido Fumagalli or Bina Mackenzie, MHRA

Telephone: 020 3080 7144 or 7229

Email: or

Clinical aspects

Mark Grumbridge

Telephone: 020 3080 7128


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

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
Welsh Government

Telephone: 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).

Download document

GlucoMen LX Sensor test strips MDA/2015/039

Help us improve GOV.UK

Don’t include personal or financial information like your National Insurance number or credit card details.