MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 10-DAY CGM SENSOR; SENSOR, GLUCOSE, INVASIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Itching Sensation (1943); Skin Irritation (2076); Swelling (2091)

Event Date 07/16/2019

Event Type  Injury  

Event Description

I have been using the abbott freestyle libre 10-day cgm for approx four months.In the beginning, when i removed the sensor after the ten day duration, i would only have red skin at the site for about two days.The past three sensors have been increasingly worse.Sixteen days ago, my sensor caused extreme itching within an hour.I left the sensor in place for nine days.Upon removal the skin was red, bumpy, itchy, and irritated.The skin has had a week to heal and the redness and itching are still present.Six days ago i prepped the site with soap and water and a skin tac barrier prep wipe instead of the supplied alcohol wipe.I applied the sensor with no irritation until day five when it became itchy.I removed the sensor today at day six and the site is again red, itchy, and bumpy.The situation has become so severe that i will not be able to use the sensors.I have contacted abbott and their only comment is to stop using the product and contact my dr.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 10-DAY CGM SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 8807499
• MDR Text Key: 151718849
• Report Number: MW5088235
• Device Sequence Number: 2
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/16/2019
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 57