YDC Product Troubleshooting Guide : 234 - WEARABLE OVERPATCH ADHESION

Complaint documentation

For this complaint code, please obtain the following:

  • N/A


Problem

Overpatch fell off or is start peeling off prior to the end of the session (G7 Only). Ensure the adhesive is not touched prior to contact. 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.
If the patient does not have issues with the G7 overlay patch, use 025. Only applicable to G7

Questions to be asked

N/A

Questions to be documented

234.1 Which overpatch was applied?

234.1.1US ONLY: Where was the decorative patch purchased?
234.1.2US ONLY: Which overpatch is experiencing the issue?

234.2 Were the steps in applying overpatch followed according to IFU?
234.3 When was the overpatch applied?
234.4 What is the specific issue with the overpatch?

Actions

1. Select from drop-down. Select from drop-down: Dexcom Overpatch, decorative overpatch, Both.

• If Dexcom Overpatch only continue to question 234.2.
• If Decorative only, advise patient that Dexcom requires use of Dexcom overpatch per IFU and continue to 234.1.1.
• If Both, continue to question 234.1.1.

1.1 US ONLY: Select from drop-down: Dexcom Website, other Source, or Unable/Unwilling to answer
1.2 US ONLY: Select from Drop-down: Dexcom Overpatch only, Decorative Overpatch only, or Both.

• If Dexcom overpatch only or both, record answer and continue 234.2.
• If answer is Decorative overpatch only, update the code to 1503 Non-Complaint with the verbiage: “Updated to 1503 since patient allegation is related to decorative overpatch rather than Dexcom overpatch.” And direct patient to the appropriate contact based on 234.1.1.

 If purchased from Dexcom website, refer PT to:

• Visit Dexcom.com/shop website to chat with an agent.
• email shop@dexcom.com directly with their question.

• If other source or unable/unwilling: refer pt back to the original source.

2. If no, advise that clean, hairless skin provides optimal adhesion.
3. Select from calendar
4. Select all that apply:

a. I had to re-position the overpatch and it dislodged my sensor
b. I had trouble pulling off the protective film
c. The overpatch got stuck to my fingers
d. I had trouble positioning it properly around the sensor
e. The instructions on how to apply the overpatch was not clear
f. The overpatch folded on itself
g. Other

Images

Reasons behind

Related issues

025 Poor Patch Adhesion

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