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Diary Mobile App

DREAMED DIABETES LTD · Model 02.XX.YY · UDI-DI 07290017735030

NDC Prescription
1
510(k) clearances
2,093
Adverse events (2 deaths)
14
Recalls
31
Facilities

Description

The Diary is a mobile app intended for use by people with diabetes, in order to log, track and share blood glucose levels, insulin delivery, physical activity, as well as carbs and meal information as part of the endo.digital Platform used by their healthcare provider. Diary also enables people to communicate with their healthcare provider. The Diary mobile app also enables the patient to see their insulin treatment recommendations provided by their healthcare provider. The insulin treatment plan is approved by your healthcare provider and he/she may have been assisted by the endo.digital algorithm before approving the plan. The Diary Mobile app is suited for both iPhone and Android users. The Bolus Calculator, a component of the DreaMed Diary App, is a diabetes management tool for people with type 1 diabetes above the age of 6 and type 2 diabetes above the age of 10, who use subcutaneous insulin injections therapy (not for pump use). This tool can help calculate their rapid acting analogs for insulin bolus doses based on user-entered blood glucose and/or meal information. The initial setup of the user’s treatment plans, and bolus calculator settings must be performed by a healthcare provider.

Recalls

DateFirmReason
2026-09-02Medtronic MiniMed, Inc.A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure of the lon
2026-06-16Medtronic MiniMed, Inc.For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will no
2025-11-13Medtronic MiniMed, Inc.When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to
2025-06-16Medtronic MiniMed, Inc.Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommen
2022-11-08Companion Medical, Inc.Diabetes management app may crash immediately upon opening, while using the app and/or while app is running in the background, which may lead to inability to use the app. An error
2019-10-01Monarch Medical TechnologiesProduct was distributed prior to approval or clearance from FDA.
2019-05-03Roche Diabetes Care, Inc.Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App.
2019-05-03Monarch Medical TechnologiesInsulin dosing calculations were erroneously high.
2018-10-08VoluntisThe firm identified an issue with the basal calculator identified on the Android version of the Insulia application. The bug could lead from low-impact to high-impact hypoglycemia
2017-06-08Roche Diabetes Care, Inc.Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. After pairing a meter with the app for the first time, a customer may encounter th

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.