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HypoMon sleep-time hypoglycaemic monitor
Recall - inadequate performance
Consumers and health professionals are advised that Aimedics, in consultation with the TGA, is recalling from the market all units of its HypoMon sleep-time hypoglycaemic monitor.
HypoMon is used by people with Type 1 diabetes aged 10-25 years to monitor blood glucose levels while they sleep. The monitor alarms in the event of a hypoglycaemic episode (also known as a 'hypo', 'low blood glucose' or 'insulin reaction').
It has been identified that HypoMon is not performing as well as expected. The rate of detection of sleep-time hypoglycaemic episodes is lower than the rate specified in HypoMon's Instructions for Use (IFU).
Information for consumers
HypoMon is intended for use as one part of a broader diabetes management regimen. If you or a child in your care uses a HypoMon, you should return the monitor and continue the normal diabetes management regimen recommended by your health professional.
Aimedics is contacting HypoMon users to provide further information about this issue, including instructions for returning the monitor and getting a full refund. If you use a HypoMon and have not been contacted about this recall, please call 1800 HYPOMON (1800 497 666) for further information.
If you have any questions or concerns about this issue, please contact your diabetes nurse educator or other health professional.
Information for health professionals
Aimedics is contacting HypoMon users to provide further information about this issue, including instructions for returning the monitor and getting a full refund.
HypoMon users should return the monitor and continue their normal diabetes management regimen.
Health professionals who are treating HypoMon users should reinforce that the monitor is a supplementary device and should not be used as the sole means of diabetes management.
If you have any questions or concerns about this issue, please call 1800 HYPOMON (1800 497 666).
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.