MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14-DAY; SENSOR, GLUCOSE, INVASIVE

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Skin Inflammation (2443)

Event Date 05/27/2019

Event Type  Injury  

Event Description

After wearing freestyle libre 14-day for 7 days, the skin became inflamed and the device and skin fell off.This was due to perspiration trapped under the adhesive, no allergy.

• Brand Name: FREESTYLE LIBRE 14-DAY
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 8675031
• MDR Text Key: 147383545
• Report Number: MW5087170
• 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: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 94