Sensor needle would not retract and detach from the sensor inserter after deployed into skin.This has happened multiple times now and happened two times in a row, 1x on (b)(6) 2020 and took a break since it hurt and caused bruising/ripped tissue.Same thing happened on (b)(6).Have contacted company and they have not done anything other than send out new ones.Devices should be recalled and new ones should be issued.Device on (b)(6) 2020 failed and also did not have a wire in the sensor to go under the skin.Fda safety report id # (b)(4).
|