| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00672-1 |
| Product Name/Description |
FreeStyle Optium Neo Blood Glucose and Ketone Monitoring System. An in vitro diagnostic medical device (IVD). |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
Abbott has identified that the Basal insulin titration feature may recommend that “0” units of insulin be taken instead of the correct insulin amount.
This issue is encountered when the average fasting blood glucose level is within the target range set by your HCP. The meter should suggest the long action dose you took the prior day, but instead is recommending “0” units. If the fasting glucose is not within the set target range, the meter will recommend the correct long acting insulin dose suggestion.
This issue was identified through an overseas complaint. There have been no reports of injury or mistreatment associated with this issue. Currently, Abbott is not aware of any patients affected by this issue in Australia and have contacted all HCPs trained to activate this feature. Patients 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. |
| Recall Action |
Recall |
| Recall Action Instructions |
The activation code for the Basal insulin Titration feature has only been provided to 15 Health Care Professionals (HCPs). Abbott Diabetes Care is advising affected HCPs to only setup the feature on unaffected devices and is providing instructions on how to identify affected devices. This information will also be provided to any new HCPs that receive training to activate this feature.
Abbott Diabetes Care has taken steps to ensure that affected HCP stock only contains the updated FreeStyle Optium Neo Blood Glucose and Ketone Monitoring System.
This action has been closed out on the 12/10/2018. |
| Contact Information |
1800 801 478 - ADC Customer Services Team |