| TGA Action ID |
RC-2025-RN-00578-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Glooko Transmitter
Model reference number: REF-0003 |
| ARTG Number |
491685 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The Glooko Transmitter was not updated with the correct time zone, resulting in an inaccurate transfer time.
In addition, the time zones could not be remotely adjusted during set up of the Transmitter by the Glooko Support Team. In certain instances the Transmitter may have been shipped to a user with a standard time zone configuration that did not correlate to their time zone.
The incorrect time zone problem impacted the recorded Transfer Time (the time that the patient’s diabetes device data was uploaded to Glooko with the Transmitter) on the Device Tab and did not impact the date and time of the diabetes data visualisation (such as graphs) within Glooko. This is because compatible diabetes devices are transmitted with their time stamps as recorded on the original device and are not impacted by the transmitter time zone.
There was only one compatible diabetes device exception, which was the NovoPen, that used the time zone settings on the Transmitter to establish the data time offset. For NovoPens uploaded via the transmitter, there is the remote possibility that the deficiency could have led to misinterpretation of patient data.
There is also a remote possibility of necessity for adjustment of insulin doses. |
| Instructions for Customers/Users |
Customers will receive the updated Instructions For Use (IFU) to review and navigate the Transmitter’s settings to confirm that it matches the appropriate timezone.
Additionally, Glooko identified the transmitters within Australia that have incorrect timezones and remotely adjusted the transmitters with incorrect time zones. Glooko completed the transmitter remote adjustment on March 31, 2025. All transmitters within Australia now have correct timezones.
This action has been finalised on 29/9/2025. |
| Action Commencement Date |
25/06/2025 |
| Responsible Entity |
|
| Contact Information |
AUNZvigilance@ul.com - Emergo Australia |