The sensor replacement alert was presented to the user on september 18, 2023, on day 125 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 throughout the insertion period.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 22 february 2024.D9.Device available for evaluation? yes, 5 december 2023.G3.Date received by manufacturer 29 january 2024.H6.Type of investigation updated to 10.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4307.
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