🇨🇦 Paradigm and MiniMed 600 and 700 series pumps

Hazard/Reason: As part of the testing for the Alternate Controller Enabled (ACE) device submission, the R&D team tested the Minimed 780g Insulin Pump at elevated and lowered height conditions relative to the infusion site per the engineering test report. The results of the testing showed that there is an unintended over or under delivery of insulin that occurs when the 780g pump is either elevated or lowered relative to the infusion site.

This page links to official sources. Verify model/lot/batch details in the official notice.