All pumps with serial numbers in the range 10171897 to 10281629 (inclusive).
Risk of delay to treatment.
There is an increased risk that the vibration alarm will not work, as a result of a changed component. This fault will only be detected at pump start up, when it will display an ‘E-7’ error message and give an audible signal, but will fail to start.
Roche will replace pumps that display this ‘E-7’ error message, but does not intend to replace all potentially affected pumps.
Identify affected pumps.
If a delay to insulin therapy could compromise patient safety, consider using an alternative device.
When using these pumps:
ensure that users are aware of the problem
ensure that users have a syringe or insulin pen available in case the pump stops
if the pump displays an ‘E-7’ error, contact Roche for a replacement
Report any adverse incidents involving these devices to the MHRA.
All those responsible for the use and maintenance of these devices, particularly diabetes departments.
This MDA has been sent to
Care Quality Commission (CQC) (headquarters) for information
Clinical commissioning groups (CCGs)
HSC trusts in Northern Ireland (chief executives)
Local authorities in Scotland (equipment co-ordinators)
NHS boards and trusts in Wales (chief executives)
NHS boards in Scotland (equipment co-ordinators)
NHS England area teams
NHS trusts in England (chief executives)
Please bring this notice to the attention of relevant employees in your establishment.
Below is a suggested list of recipients.
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
Clinical governance leads
Community diabetes specialist nurses
Diabetes nurse specialists
Diabetes, directors of
Nursing executive directors
Paediatric diabetes nurse specialists
Paediatric nurse specialists
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:
Hospitals in the independent sector
Independent treatment centres
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: email@example.com and requesting this facility.
Accu-Chek Pump Careline
Tel: 0800 731 2291
If you have any comments or feedback on this Medical Device Alert please email us at:firstname.lastname@example.org.
If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2013/008 or 2013/009/006/081/012
Sharon Knight or Patrick Sweeney
Medicines & Healthcare Products Regulatory Agency
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7202 / 6898
Fax: 020 8754 3965