The sensor replacement alert was first presented to the user on the (b)(6) 2024, day 121 post insertion.The sensor was not tested in-house, due to the sensor being broken upon arrival.The dms data showed the sensor replacement alert was triggered after the value set that triggers a sensor replacement alert declined tremendously.The in-vivo data confirms the complaint with diminished signal starting on (b)(6) 2024.The root cause of the performance failure was due to the sensor's hydrogel oxidation.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 updated to 08 may 2024.D9.Is this device available for evaluation? yes, 29 february 2024.G3.Date received by manufacturer updated to (b)(6) 2024.H3.Device evaluated by manufacturer? yes h6.Type of investigation updated to 10, 4109.H6.Investigation findings updated to 3231.H6.Investigation conclusions updated to 4307.
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