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Picis Weight Based Dose Converter
Picis Clinical Solutions, Inc. · Model 8.6 · UDI-DI 00851831007016
1
510(k) clearances
1,898
Adverse events (2 deaths)
13
Recalls
31
Facilities
Description
The Picis Weight Based Dose Converter is designed for use by trained clinicians to calculate any individual patient’s dose for a given agent based on a weight based determination by the clinician. Drug dosing for a patient must be made only after careful consideration of the full clinical status of the patient by the ordering clinician and the software provides no validation as to the appropriateness of the entered weight based dose.
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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Get your free API keyRead the docsData 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.