This report is being submitted retrospectively as part of internal review.The returned sensor was tested in-house, however, the testing results did not indicate any malfunction of the sensor.The failure mode (sensor performance deviation) could not be reproduced during the returned product analysis testing.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 which is not reproduced in the lab.As part of resolution, a return material authorization was issued for sensor replacement.No further resolution was necessary for this complaint.
|