MDN GlucoStabilizer® Insulin Dosing Calculator
MEDICAL DECISION NETWORK, LLC · Model Insulin Dosing Calculator · UDI-DI 00861133000301
Description
MDN GlucoStabilizer® Insulin Dosing Calculator is designed for use by order of a physician for hospitalized patients. It is intended to evaluate the current as well as cumulative patient blood glucose values, and based on those measurements, calculate and recommend a dose of insulin or dextrose to drive the blood glucose level either up or down towards a predetermined target range. Once that target blood glucose range has been reached, the system’s function is to recommend dosing of insulin or dextrose for the purpose of maintaining the patient’s blood glucose level in that target range. The system is programmed to provide dosing calculations of insulin and dextrose for both adult and pediatric (ages 2-18) patients.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-02 | Medtronic 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 |
| 2026-06-16 | Medtronic 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 |
| 2025-11-13 | Medtronic 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 |
| 2025-06-16 | Medtronic 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 |
| 2022-11-08 | Companion 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 |
| 2019-10-01 | Monarch Medical Technologies | Product was distributed prior to approval or clearance from FDA. |
| 2019-05-03 | Monarch Medical Technologies | Insulin dosing calculations were erroneously high. |
| 2019-05-03 | Roche Diabetes Care, Inc. | Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App. |
| 2018-10-08 | Voluntis | The 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 |
| 2017-06-08 | Roche 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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