The sensor replacement alert was first presented to the user on (b)(6) 2024, day 141 post insertion.The sensor was tested in-house, and the review of investigation analysis revealed a loss of chemical performance.The system correctly disabled the sensor when it detected the performance failure, and the system's self-test functions were working normally.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 14 may 2024.D9 device available for evaluation? yes, 12 april 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.
|