Image of Paradigm ambulatory insulin infusion pump
Risk of hypoglycaemia due to incorrect selection and delivery of bolus amount.
Medtronic has received reports of users accidentally programming the pump to deliver the maximum bolus amount.
Identify affected pumps.
Ensure that all staff and patients receive the relevant copy of Medtronic’s Field Safety Notice (FSN) dated March 2014 and follow the recommendations.
When programming insulin doses through the ‘Main Menu’, be aware that scrolling down allows the dose displayed on the screen to go from 0.0 units to the maximum programmed insulin dose.
Always confirm that the insulin dose flashing on the display screen is correct before starting delivery.
Make sure the ‘Max Bolus’ and ‘Max Basal’ settings are programmed according to individual insulin needs as determined by the healthcare professional.
All those responsible for the use, service and maintenance of these devices
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: firstname.lastname@example.org and requesting this facility.
Regulatory Affairs Manager, UK & Ireland
Croxley Green Business Park
Tel: 01923 212 213
Fax: 01923 225 273