YDC Product Troubleshooting Guide : 224 - SENSOR FAILURE

Complaint documentation

For this complaint code, please obtain the following:

  • Data
Sensor complaint documentation

For this complaint code, please obtain the following:

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

Problem

Display device shows sensor failed.
Note: NOT applicable to G7

Questions to be asked

N/A

Questions to be documented

224.1 When did the sensor failure occur? (during or after warm-up)?
224.2 Were the steps for insertion, cleaning, and starting the session followed according to the IFU?
224.3 Did the patient take medication containing acetaminophen (paracetamol)?
        224.3.1. If yes, document the dosage and frequency.
224.4 Did the patient take hydroxyurea?
        224.4.1. If yes, document the dosage and frequency.

Actions

1. Record answer.
2. Record answer.
3. Record answer.
    a. Record the dosage, frequency, and time of last dose prior to the failure. G6 is contraindicated for amounts over 1,000 mg over the course of 6 hours. Paracetamol can falsely elevate CGM readings. The length of time that acetaminophen (paracetamol) affects the system's performance is based on dose and length of time since dose.
4. Record answer.
     a. Record all usage and frequency of drug, even if the dosage is small.

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