YDC Product Troubleshooting Guide : 025 - POOR PATCH ADHESION

Problem

Patch fell off or starts peeling off prior to the end of the sensor session. Ensure BOTH liners(G6/D1) and applicator cap (if G7/D1+) are removed. 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.

Questions to be asked

N/A

Questions to be documented

025.1 Were the steps for patch adhesion followed according to the IFU?

025.2 Was the overpatch applied?

025.2.1 If yes, WHEN was the overlay patch applied? (At the start of the session, on day 3 when they noticed it was peeling up, etc.).
025.2.2 US ONLY: Did you use a Dexcom overpatch only or decorative overpatch only or both?
      025.2.2.1 US ONLY: Where was the decorative patch purchased?
025.2.3 Did the overpatch resolve the poor patch adhesion?

025.3 G7/D1+ Only: Did issue occur during the 12 hours grace period?

Actions

1. If no, advise that clean, hairless skin provides optimal adhesion. If yes, proceed with troubleshooting.
2. Select from drop-down: Yes, No, Unable/Unwilling to answer. If Yes, answer 2.2 1. If no, recommend they apply it immediately after inserting sensor.
   US ONLY G7 overpatch is NOT optional; it is required per the Dexcom G7 IFU
   2.1 Select from drop-down: Dexcom overpatch only, Decorative overpatch, Both. If Decorative overpatch or both answer 2.2.2
   2.2 Select from dropdown: Dexcom Website, Other Source, Unable/Unwilling.
   2.3 Select from drop-down: Yes, No. If no, move to code 234 - WEARABLE OVERPATCH ADHESION.
3. 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.

Images

Reasons behind

Our clinical trials show that a small percentage of users may not get the approved duration out of each sensor.  This can happen for many reasons; differences in skin types, not cleaning the area properly, or even poor adhesive. The glue is a pressure-sensitive acrylic adhesive (no latex or animal components).