05 Aug 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Australia-based medical device developer Aimedics, in consultation with Therapeutic Goods Administration (TGA), is recalling all units of its HypoMon sleep-time hypoglycaemic monitor from UK and Australia market.
Chairman of Aimedics, Mr Gordon Towell, said that, "The Aimedics board had made this voluntary recall decision as we want to investigate further technical options to improve the HypoMon user experience".
HypoMon is used by people with type 1 diabetes aged 10-to-25 years to monitor blood glucose levels while they are asleep. The monitor rings alarms in the event of a hypoglycaemic episode.
TGA 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).