Medical safety alert

Laboratory analysers: ADVIA Centaur and ADVIA Centaur XP - failure of the wash interconnect circuit board

(Hospira) Failure to detect that the ‘Wash 1’ bottle is empty or incorrect indication that the ‘Wash 1’ bottle is empty. (MDA/2013/005)

Device

Laboratory analysers for a variety of tests including HIV, tumour markers and hepatitis. Specific assays.

Laboratory analysers: ADVIA Centaur® and ADVIA Centaur® XP.

Manufactured by Siemens Healthcare Diagnostics Inc.

Specific catalogue numbers.

The following assay systems are affected by this alert:

  • ADVIA Centaur system (Cat. 078-A001-xx)
  • ADVIA Centaur refurbished (Cat. 078-A002R02)
  • ADVIA Centaur XP system (Cat. 078-A011-03)
  • ADVIA Centaur XP refurbished (Cat 078-A011R03)

Problem

A failure of the wash interconnect circuit board on the ADVIA Centaur and ADVIA Centaur XP analysers may produce the following errors:

  1. Failure to detect that the ‘Wash 1’ bottle is empty. This could result in credible but erroneous results reported on a number of tests. See affected assays listed below. Or
  2. Incorrect indication that the ‘Wash 1’ bottle is empty when actually full, causing the system to stop processing samples.

Siemens is planning software and hardware updates to resolve these issues by the end of March 2013.

The table below summarises the assays affected and what the potential effect is for each.

Assay type   Assay   Potential effect on assay results
Auto-immune   ANA   False Positive or Negative
Bone   VitD   False Positive or Negative
Cardiovascular   BNP,   High Bias
DDimer,   False Positive or Negative    
TnIUltra   Always Elevated    
Torch and Special ID   RUBG2,   False Positive or Negative
RubM,   False Positive or Negative    
ToxG,   False Positive    
ToxM   False Positive    
Reproductive Endocrinology   DHEAS,   False Positive or Negative
eE2,   False Positive or Negative    
SHBG   False Positive or Negative    
Infectious Disease   aHAVM,   False Positive
aHAVT/HAVT,   Low Bias    
aHBcM,   False Negative    
aHBcT/HBcT,   False Negative    
aHBe,   High or Low Bias    
aHBs,   False Positive    
aHBs,   False Positive    
aHBs2,   False Positive or Negative    
aHCV,   False Positive or Negative    
CHIV,   False Positive or Negative    
CMVG,   False Positive or Negative    
Conf,   False Positive or Negative    
EHIV,   False Positive    
HBeAg,   False Positive    
HBs,   False Positive    
HIV,   False Positive or Negative    
PCT,   False Positive or Negative    
SYPH   False Positive or Negative    
Immunosuppressant   CsA   Low Bias
Liver Fibrosis   HA,    False Positive or Negative
PIINP,   False Positive or Negative    
TIMP1   False Positive or Negative    
Tumour Markers / Oncology   CA153,   False Positive
CA19-9,   False Positive    
CA199A,   False Positive or Negative    
FreePSA   False Positive or Negative    
Thyroid   TSH3UL   False Positive or Negative

Action

Identify if you have affected devices.

Follow the manufacturer’s recommendations in the FSN to:

  • Monitor ‘Wash 1’ fluid levels manually.
  • Replace the ‘Wash 1’ bottle before the fluid is depleted.
  • Clear incorrect status or error messages that prohibit testing.

Contrary to the manufacturer’s FSN, consider the need to review previous results.

Action by

Laboratory staff using these systems.

Distribution

This MDA has been sent to:

  • NHS trusts in England (chief executives)
  • Care Quality Commission (CQC) (headquarters) for information
  • Health Protection Agency (HPA) (Directors)
  • HSC trusts in Northern Ireland (chief executives)
  • NHS boards in Scotland (equipment coordinators)
  • Local authorities in Scotland (equipment coordinators)
  • NHS boards and trusts in Wales (chief executives)

Onward distribution

Please bring this notice to the attention of relevant employees in your establishment. Below is a suggested list of recipients.

Trusts
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

  • Biochemists
  • Biomedical science departments
  • Clinical governance leads
  • Clinical Pathologists
  • Clinical pathology directors
  • EBME departments
  • Haematologists
  • Health and safety managers
  • Immunologists
  • Medical directors
  • Virologists

Health Protection Agency
Directors for onward distrobution to:

  • Collaborating centres
  • Consultants in communicable disease control
  • Divisional directors
  • Heads of department
  • Heads of health, safety and quality
  • HPA laboratories
  • Laboratory managers
  • Regional microbiologists
  • Risk manager
  • Safety officers

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:

  • • Private laboratories / testing services

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.

Manufacturer contact

Tony Walsh
Siemens Healthcare Diagnostics Limited
Sir William Siemens Square
Frimley
Camberley
GU16 8QD

Tel: 01908 487600
Fax: 01908 487601

Email: anthony.walsh@siemens.com

Feedback

If you have any comments or feedback on this Medical Device Alert please email us at: dts@mhra.gsi.gov.uk

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2013/005 or 2012/011/008/601/008

Technical aspects

Anthony Llewellyn or Susan Mclellan
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 6792/7215
Fax: 020 8754 3965

Email: anthony.llewellyn@mhra.gsi.gov.uk or susan.mclellan@mhra.gsi.gov.uk

Clinical aspects

Dr Nicola Lennard
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7126
Fax: 020 8754 3965

Email: nicola.lennard@mhra.gsi.gov.uk

How to report adverse incidents

Please report via our website: Reporting adverse incidents involving medical devices

Further information about CAS can be found on the CAS website

Northern Ireland

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald BT4 3SQ

Tel: 02890 523 704
Fax: 02890 523 900

Email: NIAIC@dhsspsni.gov.uk

Scotland

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Health Facilities Scotland Incident Reporting and Investigation Centre (IRIC)Health Facilities Scotland Incident Reporting and Investigation Centre (IRIC)

Wales

Enquiries in Wales should be addressed to:

Improving Patient Safety Team
Medical Directorate
Welsh Government
Cathays Park
Cardiff CF10 3NQ

Tel: 029 2082 3922

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

Download documents

Medical Device Alert: ADVIA Centaur and ADVIA Centaur XP laboratory analysers manufactured by Siemens Healthcare Diagnostics Inc.(MDA/2013/005) (72Kb)

Help us improve GOV.UK

Don't include personal or financial information, eg your National Insurance number or credit card details.