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
diabetes nurse specialists
diabetes, directors of
paediatric diabetes 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)
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.
Send enquiries about this notice to MHRA, quoting reference number MDA/2015/029 or 2015/006/011/701/006.