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Accu-Chek Spirit Combo insulin pump (Pumps with serial numbers in the range 10171897 to 10281629 inclusive)
Notice type:
Advisory
Date:
24/03/2014
Product name or type:
Accu-Chek Spirit Combo insulin pump (Pumps with serial numbers in the range 10171897 to 10281629 inclusive)
Reference:
SN2014(13)
Manufacturer Or Supplier:
Roche Diagnostics Ltd.
Target Audience:
All Hospital staff
All Nursing Home staff
Risk Managers
Nursing Managers
Hospital Pharmacists
Diabetic Clinics/ outpatients
Diabetic nurse specialists
Diabetic departments
Endocrinology units
Endocrinology Consultants
Paediatric wards
Chief Medical Scientists
Purchasing / Procurement / Material Managers
Pharmacists supplying these devices
General Practitioners
Healthcare professionals who use these devices
Healthcare professionals managing patients who use these devices
Carers
General public
Problem Or Issue:
There is an increased risk that, due to a component change, vibration alarm defects may cause an ‘E-7’ alert message. This fault will 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. The other pump alarms – visual and audible - are not affected by this issue. Pumps with serial numbers in the range 10171897 to 10281629 (inclusive) are potentially affected. These pumps were distributed to the Irish market between late 2010 and early 2012 and to date, no ‘E-7’ issues related to vibration alarm defects have been reported from Ireland.
Background Information Or Related Documents:
Accu-Chek Spirit Combo insulin pump (Pumps with serial numbers in the range 10171897 to 10281629 inclusive) Document
Roche Diagnostics Ltd. has identified an issue with the Accu-Chek Spirit Combo insulin pump which could potentially lead to a delay in therapy. Roche will replace pumps that display the ‘E-7’ message.
Actions To Be Taken:
1. Identify affected pumps.
2. If a delay to insulin therapy could compromise patient safety, consider using an alternative device.
3. 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 device
4. Ensure that appropriate personnel are made aware of this notice. Please also pass this notice on to any end user or organisation where the potentially affected insulin pumps have been transferred
Further Information:
Enquiries to the manufacturer should be addressed to:
Accu-Chek Pump Careline Number (24 hours): 1800 882 351
E-mail:
burgesshill.insulinpumps@roche.com
All adverse incidents relating to a medical device should be reported to the:
Health Products Regulatory Authority
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Telephone: +353-1-6764971
Fax: +353-1-6344033
E-mail:
devicesafety@hpra.ie
Website:
www.hpra.ie
Please quote IMB reference number V20217 for any queries in relation to this action.
Please click here to view a PDF version of this Safety Notice
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Date Printed: 18/04/2024