Device Time Offset
What has happened?
Glooko imports data from Diabetes Devices and displays the data according to the settings on the device. If the time settings on the device differ from the actual time (for example during travel through time zones or because of erroneous time setting on the device) the data will be displayed using the device time setting. This could potentially mean that the data is shown with a time offset.
In order to avoid this behavior, users are urged to ensure that the time setting on their device corresponds to the time setting on the Glooko Web App (ie. local time).
How has Glooko responded to the deficiency?
The Glooko Web App will continue to import the time settings from the device. To mitigate the risk of mistakenly synchronizing a device with the wrong time settings, Glooko has updated the Instructions For Use for its Web App. Users should review the new warning for information on how to identify time differences in the data.
Deficiencies Related to Tandem/CamAPS?
What has happened?
Glooko has made two updates to its Web App to mitigate two issues in the platform.
- Some users of the Tandem T:slim insulin pump experienced a mismatch between the duration of a sleep activity in their pump compared to the Glooko platform. The cause was a deficiency where Glooko displayed Sleep Mode-setting where the T:slim had not sent sleep mode event data. (One reported instance)
- Some users of the CamAPS FX system experienced an error message stating that their device time was offset. This was caused by the Glooko cloud-to-cloud service incorrectly tagging data as having time offset. (One reported instance)
How has Glooko responded to the deficiency?
The first software problem was resolved by a software release (version 23.3) correcting the problem that was deployed on 24 July 2023. The second problem was resolved by a software release (version 23.4) that was deployed on 3 October 2023. In addition, we have updated our IFU to include information on how to identify and manage Time Offset.
General Questions
How are clinics supposed to return the product?
The Glooko Web automatically updates to the latest software version, there are no additional actions required to mitigate the risk of this software problem.
The notice needs to be passed on to all those who need to be aware within your organisation.
Did these issues impact patient safety?
Glooko has performed a Health Hazard Evaluation and concluded that no adverse health consequences is the most likely scenario in both cases, but there is the unlikely possibility of limited or reversible hazards. There is also the unlikely possibility of the necessity for adjustment of insulin pump algorithm parameters and insulin doses.
Who is Emergo?
Emergo is the regulatory sponsor of Glooko’s products in the Australian market.
What are we expected to do?
Clinics are expected to read the message and return the Customer Response Form that was sent by Emergo as confirmation of receipt.
The Glooko Web automatically updates to the latest software version, there are no additional actions required to mitigate the risk of this software problem.
The notice needs to be passed on to all those who need to be aware within your organisation.