MAUDE Adverse Event Report: ABBOTT DIABTES CARE INC. FREESTYLE LIBRE SENSOR; SENSOR, GLUCOSE, INVASIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Purulent Discharge (1812); Itching Sensation (1943); Impaired Healing (2378); Skin Inflammation (2443)

Event Date 03/01/2019

Event Type  Injury  

Event Description

I have been using the freestyle libre for over a year now with no issues.The last two applications have left a perfectly red circle under the patch which was visible once removed.The area is very itchy, and has taken weeks to heal.It also looked like there could have been some pus on the last removal, and the area is super scaly for weeks now.I do have pictures if requested.If this continues i will have to try a different manufacturer of cgm, or not use this any more.

• Brand Name: FREESTYLE LIBRE SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABTES CARE INC.
• MDR Report Key: 8456003
• MDR Text Key: 140150250
• Report Number: MW5085176
• Device Sequence Number: 1
• 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: 03/22/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 79