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).
MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
UDI-DI/GTIN: A7630006392701, 00763000521554, 00763000639273, A7630006392301, 00199150035687, A7630007325603, A7630007325601, 00763000639235, A7630007325604, 00763000384289, 00763000521530, A7630007325401, 00763000521547, A7630006392601, A7630006392201, 00763000639228, 00199150035663, 00763000639266, A7630007325404, 00199150035694, 00763000442194, A7630007325403, 00763000521523. Software version 6.62
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.