YDC Product Troubleshooting Guide : 042 - “NO READINGS”, “SENSOR ERROR” or "BRIEF SENSOR ISSUE"

Problem

mylife App will state “Sensor Error” for more than 1 hour.

If less than 3 hours, the sensor may not need to be replaced, capture the complaint and advise to wait.
G7/D1/D1+: Message will advise “Brief Sensor Issue”.

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

042.1 How long has No readings, Brief Sensor Issue or Sensor Error been displayed?
042.2 Did the patient take medication containing acetaminophen (paracetamol)?

042.2.1 If yes, document the dosage and frequency.

042.3 Were the steps for insertion, cleaning, and starting the session followed according to the IFU?
G7 /D1+ Only: Did the issue occur during the 12-hour grace period?

Actions

1. Record the amount of time in hours. Proceed with troubleshooting.
2. If yes: Educate on paracetamol effects on the sensor. Document usage and frequency.
   2.a Acetaminophen (paracetamol) may cause the system to display false values. The length of time that acetaminophen (paracetamol) affects the system's performance is based on dose and length of time since dose. 
   Record the answer.
3. If the transmitter is not fully snapped in, readings may not be delivered to the transmitter properly. Cleaning the back of the transmitter with anything other than what is recommended in the user's guide may result in residue on the contacts; leading to inconsistency in data. G7/D1+ Only: Transmitter is pre-attached to the sensor and should be sterile from manufacture.
4. G7/D1+ Only: If yes, please advise that it is recommended to change the sensor when the session expires at 10 days. The grace period can be utilized when the end time is not convenient for the user. No replacement product will be provided for issues during the grace period. Please document the complaint.

General Information

"Bent Sensor" Allegations

• Any allegation that the patient experienced a sensor failure, sensor error, or an inaccuracy and upon removing the sensor observed that it was bent, can be noted in the narrative of the associated 013, 071, 042, 012, or etc. record. 

Images

Reasons behind

The equipment is working properly; the transmitter and display device are communicating. However, the system doesn’t understand the information coming from the body to the sensor wire. Rather than displaying a wrong value, the system may display an error until a value can be determined. Make sure the patient relies on their BG meter during this time.