Medtronic MiniMed, Inc. — Class II: MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
Medtronic MiniMed, Inc. issued a Class II recall for MiniMed Go App versions 1.0.0 and 1.1.0 due to a software error. When specific user settings are disabled, 'missed dose' and 'Correct high glucose' alerts may fail to trigger during nighttime hours.
Medtronic MiniMed, Inc., users of the MiniMed Go App (iOS/Android), and regulatory/compliance professionals responsible for mobile medical applications and insulin delivery support systems.
The failure of safety-critical alerts poses a risk of hyperglycemia due to delayed therapy. From a regulatory perspective, this highlights the complexities of logic dependencies in mobile medical apps where a non-obvious setting ('Set day and night') can suppress essential clinical notifications. This suggests a need for rigorous edge-case testing in software verification protocols for diabetes management tools.
Software development teams should verify logic pathways where user-configurable settings (e.g., day/night toggles) interact with safety-critical notifications. Regulatory and QA teams should review existing hazard analyses to ensure that notification failures leading to missed therapy are adequately mitigated and validated across all OS versions.
Class II. Reason: 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 not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.. Product: MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android). Firm: Medtronic MiniMed, Inc. (Northridge CA United States). Status: Ongoing.
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