Notice Information: - Advisory - 28/08/2012

Title:

Animas Insulin Pump (IR 1200, 2020, One Touch Ping, Vibe)

Product:

Animas Insulin Pump (IR 1200, 2020, One Touch Ping, Vibe)

Reference:

SN2012(14)

Manufacturer / Supplier:

Animas Corporation, a Johnson & Johnson Company

Target Audience:

Diabetes clinics/outpatients
Diabetes nurse specialists
Endocrinology units
Medical directors
Outpatient clinics
Paediatricians
Pharmacists
Risk managers
Supplies managers
Community nurses
General practitioners
Private medical practitioners
Practice nurses
School nurses
Clinics
Hospitals
Nursing Homes
Community Care Managers
Community Therapists
Carers

Please bring this safety notice to the attention of all who need to be aware of it.

Issue:

There is a risk of compromised insulin delivery whereby keypad buttons become unresponsive. The issue can arise due to wear and tear of keypads on the insulin pump, or sticking of keypad buttons.

Background Information / Related Documents:

Animas Corporation has received an increase in complaints relating to the durability of insulin pump keypads. Over time, tearing and peeling of the keypad buttons can occur. Keypad buttons can also stick and become unresponsive. An average time to failure of approximately 18 months was reported by the manufacturer.

Animas Corporation has a new keypad design which is incorporated into all pumps distributed post February 2012. Newer keypad designs are not affected by this problem. Animas Corporation has provided the attached Patient Notification to affected customers providing information.

The Irish Medicines Board (IMB) is issuing this Safety Notice to ensure all Animas Insulin Pump users are aware of the issue.

Action to be taken:

1. Ensure that all pump users are aware of the information provided in the attached  Field Safety Notice (FSN) issued recently by Animas.
2. Pump users experiencing problems with their device or experiencing keypad issues are encouraged to contact Animas without delay to arrange for a  replacement as outlined in the FSN.
3. Pump users are encouraged to report any issues with pump keypad both to Animas and to the IMB using the contact details provided below.

Further Information:

Enquiries to the manufacturer should be addressed to:

Animas Corporation
Animas UK & Ireland

Telephone: 1800 812 715
E-mail: AnimasUK@its.jnj.com or via the website at: www.animascorp.co.uk/contact-us

All adverse incidents relating to a medical device should be reported to the:

Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2

Telephone: +353-1-6764971
Fax: +353-1-6344033
E-mail: vigilance@imb.ie
Website: www.imb.ie

Please click here to view a PDF Version of this Safety Notice

Please click her to view a copy of the Field Safety Notice