Reissue: Nipro Diagnostics TRUEyou blood glucose test strips - risk of false low blood glucose results in some batches

Reissued - manufacturer's telephone number amended: (Nipro Diagnostics) TRUEyou blood glucose test strips - certain lots of test strips may give incorrect low blood glucose results that could lead to undetected hyperglycaemia (MDA/2016/009R)

Action

  • Identify patients who use TRUEyou and TRUEyou mini 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

Actions by

  • Healthcare personnel managing patients who use these devices

Deadlines for actions

Actions underway: 7 July 2016, actions complete: 7 August 2016

Device details

TRUEyou blood glucose test strips

TRUEyou blood glucose test strips

Product Name Item Number Lot Number Expiry Date
TRUEyou FAD E3I68-82FDL HLS1024GBY 28 April 2018
TRUEyou FAD E3I68-82FDL HLS1032GBY 22 June 2018
TRUEyou FAD E3I68-82FDL HLS1033GBY 23 June 2018
TRUEyou FAD E3I68-82FDL HLS1036GBY 24 June 2018
TRUEyou FAD E3I68-82FDL HLS1037GBY 20 June 2018
TRUEyou FAD E3I68-82FDL LS1303GBY 17 February 2018
TRUEyou FAD E3I68-82FDL LS1304GBY 17 February 2018
TRUEyou FAD E4GBY70FDL-24 HLS1037GBY 20 June 2018
Product Name Item Number Kit Lot Number Expiry Date
TRUEyou FAD E4I68-81FDL KS1222 28 April 2018
TRUEyou FAD E4I68-81FDL KS1223 28 June 2018
TRUEyou FAD E4I68-81FDL KS1570 22 June 2018
TRUEyou FAD E4I68-81FDL KS1575 28 April 2018
TRUEyou FAD E4I68-81FDL KS1784 22 June 2018
TRUEyou FAD E4I68-81FDL KS1785 23 May 2018

Problem/background

The manufacturer issued a Field Safety Notice (FSN) in May 2016. Some vials in specific lots are not sealed properly and this can affect the performance of the strips.

Manufacturer contacts

Manufacturer:

Customer Services
Nipro Diagnostics (UK) Limited

Telephone: 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 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 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
  • 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/2016/009R or 2016/005/004/291/006.

Technical aspects

Sonal Vara
MHRA

Telephone: 020 3080 7710

Email: sonal.vara@mhra.gsi.gov.uk

Clinical aspects

Mark Grumbridge
MHRA

Telephone: 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

Telephone: 028 9052 3868

Fax: 028 9052 3900

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (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

Telephone: 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

Telephone: 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).

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TRUEyou blood glucose test strips - risk of false low blood glucose results (MDA/2016/009R)

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