Safety Information

Published: 24 March 2017

Early Warning System - Monitoring Communication

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

Animas Vibe Insulin Pump and Blood Glucose Analyser - ongoing issues with screen fade, cracked battery casing and other issues. 

24 March 2017

Reports of issues with these devices have been received by Medsafe.

The reports predominantly relate to issues with screen fade or cracked battery casing. Other issues have also been reported, such as frozen/ stiff pads or software problems affecting the retention of date and time.

Products Affected

Animas Vibe Insulin Pump

Additional Information

The Animas Vibe pump is funded by PHARMAC for use by insulin dependent patients in the community to manage their insulin requirements . The pump is connected to  the  patient twenty four hours a day and as such is often exposed to a high degree of stress. The pump has a four year warranty and pumps are replaced when issues are notified. The sponsor also provides technical support direct to patients.

Regulator Actions

Medsafe is continuing to monitor reports relating to this device .

Reporting

Consumers and healthcare professionals are encouraged to report problems with this product to Medsafe.

When reporting an event relating to this type of device, Medsafe requests that the reporter be specific about the issues experienced with the device and the consequences/ outcome, if any.

Medsafe cannot give advice about an individual’s medical condition.  If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.