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EndoTool SubQ
MONARCH MEDICAL TECHNOLOGIES LLC · Model SubQ 2.0 · UDI-DI 00860003340622
NDC
Prescription
1
510(k) clearances
2,093
Adverse events (2 deaths)
13
Recalls
31
Facilities
Description
EndoTool SubQ is a software application for use by trained healthcare professionals to calculate and recommend an individual patient’s next dose of insulin to be administered subcutaneously to manage blood glucose levels in patients with hyperglycemia including adult and pediatric patients (age 2 years and above and 12 kg or more). The software is designed to recommend the insulin dose(s) and when indicated a carbohydrate dose based on the prescribing healthcare Provider’s nutritional regimen, insulin regimen, target glucose range, and patient specific characteristics.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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 | 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. |
| 2019-05-03 | Monarch Medical Technologies | Insulin dosing calculations were erroneously high. |
| 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 |
| 2017-06-08 | Roche Diabetes Care, Inc. | Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a software bug, when the OS region of the phone setting is changed, the uni |
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