Device Time Offset
What has happened?
Glooko imports data from patients' personal Diabetes Devices and displays the data
according to the settings on the device. If the time setting on the patients personal
device differs from the actual time (for example because of an erroneous time setting on
the device or during travel through time zones) the data on Glooko will be displayed
using the device time setting. This could potentially mean that the data is shown with a
time offset because Glooko shows the actual time.
To avoid this behavior, users are urged to ensure that the time setting on their personal
device corresponds to the actual time setting so it will correspond with the time on the
Glooko Web App (i.e., 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 notice for information on how to identify time differences in the data.
General Questions
How are clinics supposed to return the product?
There are no additional actions required to mitigate the risk of this issue.
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, 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.
What are we expected to do?
Clinics are expected to read the message and review the updated Instructions For Use
for information on how to identify time differences in the data.
The updated Instructions For Use needs to be passed on to all those who need to be
aware within your organization.