This report is being submitted retrospectively as part of internal review.After reviewing the sensor data in dms we can see that ec39 sensor replacement alert was triggered on 2 july 2023 at 12:53 pm.The sensor was therefore replaced and returned for investigation.Further analysis of the in vivo glucose data shows that the rate of change in the glucose values frequently exceeded 5mg/dl/min.This noise is the most probable cause of the failure.The investigation shows the system correctly disabled the sensor due to performance failure and the system's self-test functions are working normally.The failure mode could not be reproduced during the returned product analysis testing.This may occur in some instances where the failure mode that presents itself in the body is not reproduced in the lab.
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