The customer's complaint of sensor suspend was confirmed during in-vitro testing and during the review of in-vivo data.The sensor triggered sensor suspend alarm as it was observed that the led experienced a crash throughout the whole qc test.The system's self-test functions worked normally by disabling the sensor due to the detected performance failure and by triggering the ec 38 error.Since the root cause (led crash) is only related to the sensor, no further investigation needs to be carried on the transmitter.As part of resolution, the user received a new sensor and a transmitter.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 10.H6.Investigation findings updated to 4203.H6.Investigation conclusions updated to 4307.
|