YDC Product Troubleshooting Guide : 125 - WEARABLE FAILURE

Complaint documentation

For this complaint code, please obtain the following:

Data
RGA (Return Goods Authorization)

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

Problem

Wearable failure

Questions to be asked

N/A

Questions to be documented

125.1 Did the wearable fail during warm-up?
125.2 Were the steps for insertion, cleaning, and starting the session followed according to the IFU?
125.3 Did the patient take medication containing acetaminophen or paracetamol?
125.4 If yes to 125.3, document the dosage and frequency.
125.5 If yes to 125.3, did the patient take over 1000mg of Paracetamol?
125.6 Was the overlay patch used?

Actions

Document the answer.
Ensure proper steps were followed, document the answer.
Document the answer.
a. For G7, patients can take a standard or maximum acetaminophen dose of 1 gram (1,000 mg) every 6 hours and still use the sensor readings to make treatment decisions. Taking higher than the maximum dose of acetaminophen (e.g., > 1 gram every 6 hours in adults) may affect the sensor readings and make them look higher than they really are.
Document the answer.
Document the answer.
Document the answer.
a. If they haven’t applied the overlay patch, recommend they do so.

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Reasons behind

N/A

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