Home use blood glucose monitoring system: TRUEresult and TRUEtrack blood glucose test strips – risk of false low blood glucose results.

Manufactured by Nipro Diagnostics, certain lots of test strips may give incorrect low blood glucose results that could lead to undetected hyperglycaemia. This Alert refers to different blood glucose test strips to those covered by MDA/2016/009R.

Action

  • 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.

Action by

  • Healthcare personnel managing patients who use these devices.

Deadlines for actions

Actions underway: 17 August 2016

Actions complete: 12 September 2016

Device details

Product name Item number Lot number Exp. date
TRUEresult PQQ E3I24‐81‐OTC PS2190IGB 31‐Dec‐17
TRUEresult PQQ E3I24‐81‐OTC PS2319IGB 18‐May‐18
TRUEresult PQQ E3I24‐81‐OTC PS2322IGB 19‐May‐18
TRUEresult PQQ E3I24‐81 PS2190IGB 31‐Dec‐17
TRUEresult PQQ E3I24‐81 PS2319IGB 18‐May‐18
TRUEresult PQQ E3I24‐81 PS2322IGB 19‐May‐18
TRUEresult PQQ E3I24‐81 PS2407IGB 16‐Jul‐18
TRUEtrack A3I24‐81 RS4645IGB 30‐Sep‐17
Product name Item number Kit lot number Exp. date
TRUEresult PQQ E4I24‐81 KS1228 31‐Mar‐18
TRUEresult PQQ E4I24‐81 KS1229 31‐Mar‐18
TRUEresult PQQ E4I24‐81 KS1230 31‐Mar‐18
TRUEresult PQQ KS1241 KS1241 31‐Mar‐18

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.

Manufacturer contacts

Customer services
Nipro Diagnostics (UK) Limited
Tel: 0800 08 588 08

Email info-UKSO@nipro-europe.com

Distribution

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
  • 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:

  • Community pharmacists
  • 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)
  • In-house residential care homes

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

Enquiries

England

Send enquiries about this notice to MHRA, quoting reference number MDA/2016/014 or 2016/007/020/291/015.

Technical aspects

Guido Fumagalli, MHRA

Tel: 020 3080 7144

Email: guido.fumgalli@mhra.gsi.gov.uk

Bina Mackenzie, MHRA

Tel: 020 3080 7229

Email: bina.mackenzie@mhra.gsi.gov.uk

Clinical aspects

Mark Grumbridge, MHRA

Tel: 020 3080 7128

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

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
Tel: 028 9052 3868

Email: niaic@health-ni.gov.uk

Web: www.health-ni.gov.uk/niaic

Reporting adverse incidents in Northern Ireland

Please report directly to NIAIC using the forms on our website.

Scotland

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

Email: nss.iric@nhs.net

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.

Wales

Enquiries in Wales should be addressed to:

Healthcare Quality Division,
Welsh Government
Tel: 02920 823 624 / 02920 825 510

Email:Haz-Aic@wales.gsi.gov.uk

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

MDA/2016/014

Published 10 August 2016