- Medicines and Healthcare products Regulatory Agency
- 4 August 2015
- 4 August 2015
- Alert type:
- Medical device alert
- Medical specialty:
- General practice
(Roche Diabetes Care) Advice from manufacturer to users about the correct battery specification and appropriate pump settings (MDA/2015/029)
- Identify users of all Accu-Chek® Insight insulin pumps
- Ensure that all users receive the manufacturer’s field safety notice (FSN), understand the problem, use batteries meeting the specification detailed in the FSN and confirm battery type in the pump settings
- Ensure systems are in place to supply users of Accu-Chek® Insight insulin pumps with batteries meeting the specification advised by Roche
- Ensure that all users are aware that if they experience a rapid decrease in power they should contact the Accu-Chek® Pump Care Line on 0800 731 22 91
- Complete and return the FSN acknowledgement form to Roche
Everyone responsible for the use and maintenance of these devices, particularly diabetes care specialists.
Deadlines for actions
Actions underway: 3 September 2015, actions complete: 1 October 2015
Roche has identified that the use of low-quality batteries or users incorrectly confirming the battery type in the pump settings can lead to unexpected rapid power depletion or a shutdown of the pump. If this goes undetected, patients could experience hyperglycaemia due to under delivery of insulin.
Roche has provided updated handling instructions and battery model recommendations in their FSN issued in June 2015 (manufacturer’s reference: SB_RDC_2015_04) but has not had enough replies to know that healthcare providers and users have received and acted on this advice.
Roche Diabetes Care
Accu-Chek® Pump Care telephone: 0800 731 22 91
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
- diabetes clinics/outpatients
- diabetes nurse specialists
- diabetes, directors of
- EBME 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:
- community pharmacists
- general practitioners
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/2015/029 or 2015/006/011/701/006.
Jenifer Hannon or Roopa Prabhakar, MHRA
Tel: 020 3080 7153 / 7293
Mark Grumbridge, MHRA
Telephone: 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
Telephone: 028 9052 3868
Fax: 028 9052 3900
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
Telephone: 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
Telephone: 01267 225278 / 02920 825510
Reporting adverse incidents in Wales
Published: 4 August 2015
Issued: 4 August 2015
Alert type: Medical device alert
Medical specialty: General practice