The review of the glucose plot showed two consecutive drop out phases 14 days apart that triggered the sensor replacement alert on november 13, 2023.The returned sensor was tested in-house, and the failure mode could not be reproduced.This may occur in some instances where the failure mode that presents itself in the body is not reproduced in the lab.The potential root cause for such failure mode may be related to an issue with the sensor electronics, for example the led behavior at the time, or the in vivo state of the sensor hydrogel.As part of resolution, the rma was authorized for sensor replacement.B4.Date of this report updated to 21 march 2024.G3.Date received by manufacturer updated to 09 february 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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