Medtronic MiniMed, Inc. — Class II: MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
Medtronic MiniMed, Inc. has initiated a Class II recall for specific models of the MiniMed 780G Insulin Pump due to a software anomaly. When paired with the Instinct sensor, the device may unexpectedly stop insulin delivery and display sequential error messages (Pump Error 53 followed by Pump Error 23).
Manufacturers of insulin delivery systems, specifically those involving software-driven pump and sensor integration, as well as regulatory, QA, and software engineering teams managing these devices.
This event highlights critical risks associated with device interoperability and software stability in closed-loop or paired systems. The cessation of insulin delivery presents significant clinical risks, including hyperglycemia and diabetic ketoacidosis. From a regulatory perspective, this underscores the importance of rigorous software validation for specific sensor-pump pairing configurations and the need for robust error-handling protocols that prioritize continuous therapy delivery.
Verify software-sensor compatibility matrices in existing risk files. Ensure field action procedures adequately address localized software anomalies that trigger immediate therapy cessation. Update post-market surveillance protocols to monitor for specific error code sequences (53 and 23) in paired-device environments.
Class II. Reason: A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or diabetic ketoacidosis (DKA).. Product: MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896. Firm: Medtronic MiniMed, Inc. (Northridge CA United States). Status: Ongoing.
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