Animas Vibe insulin pumps

Safety advisory - potential battery issues if compartment cracked

14 October 2016

Consumers and health professionals are advised that Australasian Medical & Scientific Limited, in consultation with the TGA, is issuing a safety advisory regarding the Animas Vibe insulin pump due to the potential for battery compartment damage to affect the supply of power to the unit.

Australasian Medical & Scientific Limited advises that the pump may lose its waterproof capability and/or the ability to maintain a reliable power connection between the battery and the battery contacts if the compartment is cracked. Cracking is most commonly caused if the pump is dropped or the battery compartment cap is over-tightened. In the event that the battery power is interrupted, the pump may not alert the patient of an issue through alarms. In addition, moisture in the pump can contribute to pump failure and the suspension of insulin delivery.

Insulin pumps are used to automatically deliver the required doses of insulin in people with certain types of diabetes.

Animas Vibe insulin pumps Animas Vibe insulin pumps

Information for consumers

If you or someone you provide care for uses an Animas Vibe insulin pump be alert to this issue.

Australasian Medical & Scientific Limited advises pump users to regularly inspect their pump for cracks and replace the pump battery cap every six months.

If you drop your pump or hit it against something hard, inspect it to be sure it is still working properly. When you inspect the battery cap ensure the coloured O-ring is not damaged and that the small air hole in the centre of the cap is not blocked.

Do not use excessive force to tighten the cap. The owner's booklet provides further information about what to look for and how to keep the pump well maintained.

Patients are advised to contact Australasian Medical & Scientific Limited customer support on 1300 851 056 if they suspect damage to their pump or have any questions or concerns.

Information for health professionals

If you are treating a patient who uses an Animas Vibe insulin pump be aware of this issue.

Advise patients to regularly inspect their pumps for cracks and to replace the pump battery cap every six months.

If you have any questions or concerns about this issue contact Australasian Medical & Scientific Limited customer support 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.