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مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-13-04-25-852
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Glooko Web Application
الأجهزة المتأثرة
UDI 00855093008026
الممثل المعتمد
Bio Standards
سبب المشكلة
Glooko imports data from diabetes devices and displays the data according to the device's settings. If the time settings on a diabetes device are different from the actual local time (for example, due to incorrect time settings on the device or while traveling between time zones), the data will be displayed using the device's time setting. This means that your reference data displayed on Glooko may appear with a time discrepancy.
الإجراء التصحيحي
To avoid this issue, users are advised to ensure that the time settings on their personal diabetes device match the local time, so the data is displayed correctly in the Glooko Web Application. To prevent future time discrepancies, Glooko is updating its current Instructions for Use and adding a user warning about the issue and how to correct it, refer to the attachment for more information. Manufacturer Action: Instructions and correction.
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