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Consumers and health professionals are advised that AMSL Diabetes, in consultation with the TGA, is recalling Animas 2020 and IR 1200 insulin pumps.
Animas 2020 and IR 1200 insulin pumps deliver continuous doses of insulin to help patients with diabetes maintain safe blood glucose levels.
Due to a software problem in relation to an end of service life date, these insulin pumps will cease operation on 1 January 2016.
In the case of Animas 2020 insulin pumps, on this date the devices will no long deliver insulin and will display at 'Call Service' alarm.
For IR 1200 insulin pumps, on this date the device's calendar will revert to a previous year. While the insulin pump will continue to deliver insulin, this issue will affect any data management software being used with the device.
The end of service life date was not originally identified in the product labelling for these insulin pumps.
AMSL Diabetes has been replacing the affected devices with Animas Vibe insulin pumps. However, its records show that in some cases patients who have Animas 2020 or IR 1200 insulin pumps have not yet arranged for a replacement device, and in other cases patients have received an Animas Vibe insulin pump but have not yet returned the older device.
Information for consumers
AMSL Diabetes is writing to Animas 2020 and IR 1200 insulin pump users to provide further information about this issue, including instructions to return the affected devices in a supplied prepaid envelope.
There are also instructions on what to do if you do not wish to return the affected pump, or if you no longer have the device in your possession.
Please note that this issue will not affect the operation of these insulin pumps prior to 1 January 2016. In the meantime, AMSL Diabetes has been replacing the affected devices with Animas Vibe insulin pumps.
If you or someone you care for uses an Animas 2020 or IR 1200 insulin pump and you have not received a letter from AMSL Diabetes, contact AMSL Diabetes on 1300 851 056.
If you have any questions or concerns about this issue, speak to your diabetes nurse educator or other health professional. Alternatively, you can contact AMSL Diabetes on 1300 851 056.
Information for health professionals
AMSL Diabetes is writing to Animas 2020 and IR 1200 insulin pump users to provide further information about this issue.
If you are treating a patient who uses an Animas 2020 or IR 1200 insulin pump, ensure that they are aware of this issue and instruct them to follow the recall procedures.
Reassure them that this issue will not affect the operation of these insulin pumps prior to 1 January 2016.
If they have not received a letter from AMSL Diabetes, or have more questions or concerns about this issue, advise them to phone 1300 851 056.
If you have any questions or concerns about this issue, contact AMSL Diabetes on 1300 851 056.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.