- Identify patients who use TRUEresult, TRUEresult twist, and TRUEtrack blood glucose meters.
- Advise patients to discontinue use of any blood glucose test strips with affected lot numbers.
- Return affected test strips to manufacturer for replacement.
- Ensure that patients are aware of this information and that they have an alternative testing means, if required.
- Ensure the patient can continue to monitor their blood glucose effectively.
- If patients are concerned about their blood glucose readings when using this meter, advise them to contact their healthcare professional.
- Healthcare personnel managing patients who use these devices.
Deadlines for actions
Actions underway: 17 August 2016
Actions complete: 12 September 2016
||Kit lot number
Problem / background
The manufacturer issued a Field Safety Notice in July 2016.
Some vials in specific lots are not sealed properly and this can affect the performance of the strips.
Nipro Diagnostics (UK) Limited
Tel: 0800 08 588 08
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 nurses
- Diabetes clinics/outpatients
- Diabetes nurse specialists
- Diabetes, directors of
- District nurses
- Endocrinology units
- Health and safety managers
- Health visitors
- Hospital at home units
- Hospital pharmacies
- Hospital pharmacists
- Medical directors
- Minor injury units
- NHS walk-in centres
- Paediatrics departments
- Pharmaceutical advisors
- 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:
- Community pharmacists
- General practitioners
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)
- In-house residential care homes
Establishments registered with the Care Quality Commission (CQC) (England only)
- Adult placement
- Care homes providing nursing care (adults)
- Care homes providing personal care (adults)
- Domiciliary care providers
- Further education colleges registered as care homes
- 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: email@example.com and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2016/014 or 2016/007/020/291/015.
Guido Fumagalli, MHRA
Tel: 020 3080 7144
Bina Mackenzie, MHRA
Tel: 020 3080 7229
Mark Grumbridge, MHRA
Tel: 020 3080 7128
Reporting adverse incidents in England
Through Yellow Card
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,
Department of Health,
Social Services and Public Safety
Tel: 028 9052 3868
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
Tel: 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,
Tel: 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)