YDC Product Troubleshooting Guide : 001 - Warmup takes longer than expected

Complaint documentation

Data
Receiver SN
RGA (Return Goods Authorization)

Sensor complaint documentation

For this complaint code, please obtain the following:

Sensor insertion area
Sensor insertion date (if applicable)
Sensor lot number

Product	mylife App
System component	DX G6 Sensor/Applicator
Dexcom TSG Version	TSG-339266 Rev. 002

Problem

After starting the session, the warm up period never ended, or the user was not prompted to enter required initial calibration, Readings have not been displayed.

G6/D1: If the user is in “No Cal” by using the sensor code, they will not receive the prompt.

If off-label insertion site is indicated, remind the patient of the approved site(s) and that if placed in other areas, the Dexcom System may not function properly. Document this education in the Discussion/Resolution section.

Questions to be asked

N/A

Questions to be documented

001.1 How long did the warm up period last?

001.2 What was displayed during the warm up period?

Actions

The warm up period may last beyond labeled duration. If the countdown indicator has not moved for the labeled duration, advise the user to stop the session and replace the sensor.
If there was an alert, the warm up period may last longer than the labeled duration. Create an complaint for any alerts.

Reasons behind

N/A

Related issues

N/A

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