It has come to our attention that medical device manufacturer, Abbott Diabetes Care, has issued a field safety notice concerning a Glucose and ketone monitoring system - Freestyle Optium Neo Blood Glucose and Ketone Monitoring System.
The manufacturer has become aware that a basal insulin titration feature of the affected product, which provides users with a long acting insulin dose suggestion, may in error recommend "0" units of insulin to be taken.
This issue is encountered when the feature has been activated by healthcare professional (HCP), while the patient is in glycaemic control and their average fasting blood glucose level is within the target range that the HCP has set. The meter should suggest the basal dose that the patient took the prior day, but instead is incorrectly recommending "0" units. Therefore, the manufacturer advises the users not to use this affected feature, if activated.
According to the manufacturer, the issue would not pose a significant risk to user's health or safety. The users may continue to test their blood glucose and/or ketones as this issue does not impact blood glucose and/or ketone results received from the meter. As a permanent solution, the manufacturer will update the firmware of the product.
According to the local supplier, the affected product is distributed in Hong Kong; nonetheless, only those units with activated basal insulin titration feature would be involved.
If you are in possession of the affected products and currently using the long acting suggestion, please contact your supplier and HCP for necessary actions.
Posted on 24 August 2015