VITEK®2 Identification (ID) / Antimicrobial Susceptibility Test (AST) Cards – potential false resistance for antibiotics on the AST panel, leading to false negative ESBL test or false positive urea (URE) reaction on ID cards

Manufactured by BioMérieux – due to a manufacturing issue, some test card pouches might be damaged, resulting in antibiotic degradation.

Action

  • Ensure all relevant members of staff receive the manufacturer’s Field Safety Notice and that they understand the problem and the actions to be taken.
  • Destroy any defective cards
  • Contact Biomerieux to acknowledge receipt of the Field Safety Notice (dated 20 April 2017) even if you don’t have affected devices left in stock.
  • Consider the need to repeat test if you observe any of the following results from the affected lots:
    • a resistant imipenem result, particularly if unexpected and/or inconsistent with other results
    • a resistant or intermediate nitrofurantoin result which is unusual or inconsistent with other results
    • a resistant oxacillin or erythromycin result which is unusual or inconsistent with other results
    • any quality control test result with these agents that is outside of the expected range
  • If concerns exist after repeat testing, alternative methods of establishing drug susceptibility should be used
  • As part of your review processes, report any incorrect results to MHRA

Action by

  • Directors of pathology
  • Laboratory managers
  • Lead biomedical scientists (microbiology)

Deadlines for actions

Actions underway: 29 August 2017

Actions complete: 14 September 2017

Device details

All VITEK® 2 AST Test Cards manufactured before 16 March 2017 are affected.

Images with examples of a defective pouch together with a spreadsheets of lot numbers and expiry dates of affected products is listed both in the manufacturer’s Field Safety Notice and in the pdf file attached to this alert at the bottom of the page.

Problem / background

If moisture gets into the damaged test card pouches, it can stop the antibiotics working properly.

The manufacturer’s investigation found that the root cause of the problem was a combination of stitch seal wheel design/positioning on the manufacturing equipment, and product shipping/handling. The stitch seal wheels on the manufacturing equipment have now been replaced with a new design.

Manufacturer contacts

Lena Duddell
BioMérieux UK Limited
Grafton House, Grafton Way
Basingstoke, Hampshire
RG22 6HY
UK

Telephone: 01256 461 881

Email: lena.duddell@biomerieux.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:

  • Biomedical science departments
  • Clinical pathology directors
  • Medical directors
  • Purchasing managers
  • Supplies managers

Public Health England

Directors for onward distribution to:

  • PHE laboratories
  • Laboratory managers
  • Regional microbiologists
  • Risk manager

Independent distribution

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

  • Hospitals in the independent sector
  • Independent treatment centres
  • Nursing agencies
  • Private medical practitioners

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/2017/021 or 2017/004/025/291/012.

Technical aspects

Rehad Abdool Gaffoor, MHRA

Tel: 020 3080 6459

Email: rehad.abdoolgaffoor@mhra.gov.uk

Clinical aspects

Devices Clinical Team, MHRA

Tel: 020 3080 7274

Email: DCT@mhra.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

Northern Ireland Adverse Incident Centre (NIAIC)

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 documents

MDA/2017/021 - VITEK®2 Identification (ID) / Antimicrobial Susceptibility Test (AST) Cards

Published 14 August 2017