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

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Document details:

Type:	Medical Device Alert
Series No:	MDA/2013/005
Audience:	Healthcare professionals
Published:	14 February 2013 at 16:00
Format:	Electronic only
Size:	A4
Pages:	5
Price:	Free
ISBN/ISSN:
Author:
Copyright:	Crown

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Ref: MDA/2013/005 | Issued: 14 February 2013 at 16:00

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 (external link)

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

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) (external link)

.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

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)

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.

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

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.

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.

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

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

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