YDC Product Troubleshooting Guide : 021 - SKIN REACTION

Problem

Skin reaction at insertion site.

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.

Every patient reporting a skin reaction should receive education about barrier products and point the patient to the Dexcom Skin FAQ on the website. For more information, see the file in the extras below.

Questions to be asked

N/A

Questions to be documented

021.1 Describe the skin reaction from insertion to onset (as stated by patient)?  Check list format select all that apply.

1. Itching
2. Burning
3. Rash
4. Redness
5. Inflammation/Swelling.
6. Pimples or bumps
7. Blisters
8. Dry/Flaky skin
9. Scar
10. Drainage/Watery
11. Pustules
12. Infection
13. NI
14. Other_______

021.2 Describe the location of the skin reaction? Drop down, select all that apply.

1. underneath sensor pod area only
2. under entire patch area
3. extended beyond the patch perimeter.
4. Overlay Patch
5. Needle puncture site
6. NI
7. Other ______

If 021.2 Answer is 5, then ask the following below two questions.
a. Did the patient mention if they are immunocompromised (has a weakened immune system)? Yes or No.
b. If Yes, clarify in free text field. Examples, people being treated for cancer, organ transplant, HIV, or those receiving high-dose oral steroids.
c. What is the patient’s current status? Free text field.

US ONLY: If 021.2 Answer is 4, then ask the following questions:
d. Did you use a Dexcom Overpatch only or a decorative overpatch only, or both?
e. Where was the decorative patch purchased?

021.3 Description of the Treatment (If Any) Document the name of each product used in free text field.

1. Over the Counter (OTC) Topical Cream or Ointment
2. Prescription Topical Cream or Ointment
3. Prescription Oral or IV Medication
4. Incision and Drainage
5. Kept clean and dry.
6. No Treatment
7. NI
8. Other _______

If 021.3.1 Answer is 1, 2, 3, 4 then ask the following below two questions.
a. What is the name of the medication? Free text field.
b. What date did the patient start taking the medication? Date selection field.

If 021.3.2 Answer is E, then ask the following below two questions.
a. What was the date of the procedure? Date selection field.
b. Who performed the procedure? Free text field.

021.4 How was the area prepared before placing the sensor on the body?

1. Soap/Water
2. Alcohol
3. Did not cleanse area.
4. Skin Prep/Barrier applied
5. NI
6. Other _______

If 021.4 Answer is 4, then ask the following Below two questions.

1. What product(s) were used? Free text field.
2. Did the product help minimize or prevent the skin reaction?

021.5 Do you have a photo for our records? Yes or No

Actions

1. Record answer to the question. If additional information about the reaction is provided or N. Other is selected, document in open text field.
2. Record answer to the question. Assist patient with identifying specific location on the body and in relation to the location of the sensor. If additional information about the reaction location is provided or G. Other is selected, document in open text field.
   a. If E, answer question 2.a Yes or No. If Yes, clarify in open text field 2.a.a and 2.b in open text field. 
3. Record answer to the question. Document all medical intervention, prescription, health care provider contacts for this event. If additional information about the treatment is provided or I. Other is selected, document in open text field.
   a. If A, B, C, D answer question 3.1.a free text field and 3.1.b in date selection field.
   b. If E, answer question 3.2.a date selection field and 3.2.b in open text field.
   
4. Record answer to the question. If additional information about the preparation of area is provided or F. Other is selected, document in free text field.
   a. If D, answer question 4.a open text field and 4.b Yes or No.
5. Record answer to the question. If yes, have user email photo to Tech Support and attach photo to complaint record.

EXTRA: 

Allow the patient to wait to see if symptoms subside. If symptoms do not subside or appear to be getting worse.  They may want to seek help from a healthcare professional.  This includes but is not limited to pus, draining, fever, infection, or discomfort.  Avoid inserting the sensor in areas that are likely to be bumped, pushed or compressed or of skin with scarring, tattoos, or irritation as these are not ideal sites to measure glucose. 

Skin reaction:

Link FAQ: https://www.dexcom.com/de-DE/faq-search-page

PDF file about skin reaction:

There may be times a patient asks for the FAQ to be mailed to them, however the agent does not need to offer them the email.

Please do not forward emails sent to patients to intl.techsupport@dexcom.com as these emails would contain sensitive patient information.

Images

n/a

Reasons behind