Medtronic MiniMed, Inc.: Continuous Glucose Monitor Retrospective Data Analysis Software
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CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by healthcare professionals (HCPs) for Total Daily Dose (TDD) or Long-acting insulin when calculating the Carb Ratio, Insulin Sensitivity Factor (ISF), and Max Recommended value for Rapid-acting insulin. Instead, the calculator continues to use the system-recommended values, resulting in incorrect rapid-acting insulin parameters. If an HCP or patient inputs these incorrect setting values into the patient's MiniMed Go app, the patient could deliver higher or lower insulin doses compared to their insulin needs, potentially leading to over/under delivery of insulin with a severity ranging from Catastrophic (death from severe hypoglycemia) to Minor (self-treatable hypoglycemia/hyperglycemia).
- Tags
- FDA recall, medical device, class 1, Clinical Chemistry, Software design, Open, Classified
- Related exam domains
- CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security; CISA 3: Information Systems Acquisition, Development and Implementation; CISA 5: Protection of Information Assets
- Source record id
- Z-0203-2027
- First seen by InfoSec Signals
- Oct 23, 2026
Source: openFDA device recalls, U.S. Food and Drug Administration about this source more from it
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