The sensor replacement alert was presented to the user on (b)(6) 2024, day 121 after insertion.The returned sensor was tested in-house, and it revealed a loss of chemical performance which caused a decline in the signal modulation.The system correctly disabled the sensor due to performance deviation, and the system's self-test functions were working normally.The root cause of the failure was due to the sensor's hydrogel oxidation.As part of resolution, the rma was authorized for sensor replacement.B4.Date of this report 10 may 2024.G3.Date received by the manufacturer? 07 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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