Accu-Chek mobile meter and Accu-Chek mobile test cassette - risk of falsely high readings if testing procedure is not followed

(Roche Diabetes Care) Home-use blood glucose monitoring system - if patients do not follow specific testing procedure they may take insulin when they don't need it (MDA/2015/031)


  • Identify patients who use this system
  • 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 specific testing procedure, which includes making sure that they:
    • clean and dry their hands before testing
    • apply the blood droplet immediately in a steady motion within the testing area, without pressing on it
  • Ensure you are familiar with the technology of this device and can show the patient how to use it correctly
  • Ensure the patient can continue to monitor their blood glucose effectively
  • Ensure this guidance is incorporated into local protocols

Action by

Healthcare personnel managing patients who use these devices.

Deadlines for action

Actions underway: 25 August 2015, actions complete: 18 September 2015

Device details

Accu-Chek mobile meter and Accu-Chek mobile test cassette

Problem/ background

The system uses strip-free technology, so users need to follow a specific testing procedure that is different to standard meter and strip systems.

We issued an alert in 2014 (MDA/2014/021) but we continue to receive reports of false high readings relating to this device. We continue to work with the manufacturer to further reduce the potential for false high readings

Manufacturer contacts

Roche Diabetes Care
Telephone: Accu-Chek Careline: 0800 701 000



  • Care Quality Commission (CQC) (headquarters) for information
  • directors of public health
  • OFSTED (directors of children’s services) for information
  • Public Health England (for information)
  • Social services in England (directors)

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:

  • all wards
  • ambulance services directors
  • ambulance staff
  • chief pharmacists
  • clinical governance leads
  • community diabetes specialist nurses
  • community hospitals
  • community midwives
  • community nurses
  • diabetes clinics/outpatients
  • diabetes nurse specialists
  • diabetes, directors of
  • dietetics departments
  • district nurses
  • health visitors
  • hospital at home units
  • hospital pharmacies
  • hospital pharmacists
  • nhs walk-in centres
  • outpatient clinics
  • paediatricians
  • paediatrics departments
  • pharmacists
  • point of care testing co-ordinators
  • purchasing managers
  • risk managers
  • school nurses
  • walk-in centres

Public Health England

Directors for onward distribution to:

  • collaborating centres
  • consultants in communicable disease control
  • divisional directors
  • heads of department
  • heads of health, safety and quality

NHS England area teams

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

  • community pharmacists
  • general practice managers
  • general practice nurses
  • general practitioners

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
  • day centres (older people, learning disabilities, mental health, physical disabilities, respite care, autistic services)

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
  • 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/2015/031 or 2015/006/015/210/001.

Technical aspects

Bina Mackenzie or Sonal Vara
Telephone: 020 3080 7229 / 7710

Email: or

Clinical aspects

Dr Camilla Fleetcroft
Telephone: 020 3080 6097


Reporting adverse incidents in England

Through the Yellow Card website.

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

Report directly to NIAIC using the forms on the 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 should report to Health Facilities Scotland.

Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients should report to Health Facilities Scotland.

Private facilities providing care to private clients should report to the Care Inspectorate and MHRA.


Enquiries in Wales should be addressed to:

Healthcare Quality Division
Welsh Government
Telephone: 1267 225 278 / 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 documents

MDA-2015-031 Accu-Chek mobile meter and Accu-Chek mobile test cassette

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