Medtronic MiniMed, Inc.: Continuous Glucose Monitor Retrospective Data Analysis Software

Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.

Tags

FDA recall, medical device, class 1, Clinical Chemistry, Software change control, Open, Classified

Related exam domains

CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security; CISM 3: Information Security Program

Source record id

Z-0594-2026

First seen by InfoSec Signals

Sep 23, 2026

Source: openFDA device recalls, U.S. Food and Drug Administration · about this source · more from it

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