Accu-Chek® Insight Insulin pump system: risk of over- or under-infusion of insulin
- Medicines and Healthcare products Regulatory Agency
- 1 September 2016
- 1 September 2016
- Alert type:
- Medical device alert
Manufactured by Roche Diabetes Care - inadequately detailed handling instructions of the 'Key Lock' function of the pump may lead to unintentional operation, which could result in rapid and severe deterioration of health e.g. hypoglycaemia or diabetic ketoacidosis.
Identify users of the Accu-Chek Insight insulin pump system.
Healthcare professionals should ensure that:
patients/carers understand that the Quick Bolus keys on the top of the Accu-Chek Insight insulin pump are NOT locked by the Key Lock function
patients/carers receive a copy of manufacturer’s Field Safety Notice (FSN), and are made aware of the enhanced handling instructions
all new patients/carers have a copy of the FSN with their Accu-Chek Insight pump system.
GPs should note that this is for their information only.
All healthcare workers responsible for patients who use these devices.
Deadlines for actions
Actions underway: 8 September 2016
Actions complete: 22 September 2016
Roche Diabetes Care Accu-Chek Pump Care Line
Telephone: 0800 731 22 91
Manufacturer FSCA Reference: SB_RDC_2015_05
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- Community diabetes specialist nurses
- Community hospitals
- Community nurses/District nurses
- Diabetes clinics/outpatients
- Diabetes nurse specialists
- Diabetes, directors of
- EBME departments
- Emergency departments
- Equipment stores
- Outpatient clinics
- Paediatric diabetes nurse specialists
- Risk managers
- Supplies managers
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- General practitioners - for information only
Establishments registered with the Care Quality Commission (CQC) (England only)
- 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.
Send enquiries about this notice to MHRA, quoting reference number MDA/2016/015 or 2015/008/019/701/009.
Roopa Prabhakar and Helen Stidwill, MHRA
Tel: 020 3080 7293 and 020 3080 7047
Mark Grumbridge, MHRA
Tel: 020 3080 7128
Reporting adverse incidents in England
Alerts in Northern Ireland are distributed via the NI SABS system
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre,
Department of Health,
Social Services and Public Safety
Tel: 028 9052 3868
Reporting adverse incidents in Northern Ireland
Please report directly to NIAIC using the forms on our website.
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre,
Health Facilities Scotland,
NHS National Services Scotland
Tel: 0131 275 7575
Fax: 0131 314 0722
Reporting adverse incidents in Scotland
NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Published: 1 September 2016
Issued: 1 September 2016
Alert type: Medical device alert