MAUDE Adverse Event Report: ABBOTT DIABETES CARE, INC. LIBRE FLASH GLUCOSE MONITOR; SENSOR, GLUCOSE, INVASIVE - FREESTYLE LIBRE PRO, FLASH GLUCOSE MONITORING SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Itching Sensation (1943); Swelling (2091); Reaction (2414)

Event Date 07/24/2019

Event Type  Injury  

Event Description

Applied libre flash glucose monitor as instructed by mfr.Experienced some itching while wearing.When glucose monitor removed, severe dermatologic reaction noted.Skin inflamed, swollen, weeping, red, with bumps and blisters noted.Product has been used for 5 months previously, had reaction one other time.Abbott notified.Fda safety report id# (b)(4).

• Brand Name: LIBRE FLASH GLUCOSE MONITOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE - FREESTYLE LIBRE PRO, FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC.
• MDR Report Key: 8838021
• MDR Text Key: 152630022
• Report Number: MW5088430
• 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: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 54 YR
• Patient Weight: 109