The sensor replacement alert was first presented to the user on (b)(6) 2024, day 21 post insertion.From the return material analysis testing, however, the sensor did not reveal any malfunction.This may occur in some instances where the failure mode that presents itself in the body is not reproduced in the lab.The review of the sensor data in dms showed the sensor was taking longer than usual to stabilize after insertion, which eventually triggered the sensor replacement alert.The potential root cause for the slow recovery could be due to inadequate hydration of the sensor's hydrogel.As part of resolution, a return material authorization was issued for sensor replacement.No further resolution was necessary for this complaint.B4.Date of this report on (b)(6) 2024 g3.Date received by the manufacturer? 10 may 2024 h3.Device evaluated by manufacturer? yes h6.Type of investigation updated to 10, h6.Investigation findings updated to 3231, h6.Investigation conclusions updated to 4307.
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