The missed hypoglycemic episode occurred during the first 4 days following the insertion, when the system was still stabilizing after the insertion procedure.The customer also entered calibration entries during periods of rapid glucose change, which very likely made the inherent lag of the system more apparent.A review of the sensor performance in the two weeks following the event showed an improved accuracy in sensor readings, as the customer started calibrating the system properly when prompted by the system.All performance parameters are within expectations.Multiple attempts were made to gather more information about the incident and how it was resolved.However, user remained unresponsive.The system is currently performing within expectations.H3.Device evaluated by manufacturer?yes.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4315.
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