Laboratory analyser: Mass spectrometers manufactured by Waters Corporation, a US corporation (MDA/2012/083)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2012/083 or 2012/010/022/601/011

Technical aspects
Susan Mclellan or Bina Mackenzie
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ
Tel: 020 3080 7215 / 7229
Fax: 020 8754 3965
Email: susan.mclellan@mhra.gsi.gov.uk or bina.mackenzie@mhra.gsi.gov.uk

Clinical aspects
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

How to report adverse incidents in Northern Ireland

Please report directly to NIAIC, further information can be found on the NIAIC website (external link)
Further information about SABS can be found on the SABS website (external link)

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

The ion block source heater can fail, potentially leading to inaccurate results which may not be picked up by quality control or internal standard monitoring.

Assays with shorter dwell times are most affected, including neonatal screening for phenylketonuria, medium chain acyl CoA dehydrogenase deficiency and maple syrup urine disease.

• Identify if you have affected devices.
• If you have an affected product, replace the heater or contact Waters for a field service engineer to carry out a replacement, as described in the manufacturer’s Field Safety Notice.
• If your heater has failed, you should consider the need to review patient results.

The field service engineer can perform an ‘insulation resistance test’ to determine if the ion block source heater has failed. If the results of the test indicate a failure of the ion block source heater then further data checks will be required, as described below:

• review data for a change in the performance / increased imprecision of the batch QCs at any level
• review data for a change in the sensitivity of the assay (this can be detected by reviewing analyte and internal standard area responses):
  • the response for samples in a submitted batch will have increased variability
  • for some samples there may be no response for both analyte and internal standard, while others quantify with no issues and with expected responses
• review the internal standard area response from the calibrators. Any deviation or increased variability from the expected internal standard response should be investigated further. Faulty heaters will exhibit a larger percent relative standard deviation or the internal standard area in the calibrators, which can lead to a change in the precision of the assay for samples where the internal standard response is below the expected response.

If a heater failure is detected, review relevant patient results and consider the need to discuss any aberrant results with your laboratory director.

Action by

Laboratory staff who use this device.

This MDA has been sent to:

• NHS trusts in England (chief executives)
• Care Quality Commission (CQC) (headquarters) for information
• 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
• Haematologists
• Medical directors
• Medical libraries
• Medical physics departments
• Risk managers

Independent distribution

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

• Pathology laboratories

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.

UK

Wendy Baker
Waters Corporation

Tel: 0161 946 2718
Fax: 0161 946 2597
Email: Wendy_Baker@waters.com

US

Waters Corporation
34 Maple Street
Milford
Massachusetts
01757
USA

Tel: +1 508 482 3574
Fax: +1 508 482 2543
Email: Kathleen_Morahan@waters.com

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