MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE SENSOR; FREESTYLE LIBRE GLUCOSE MONITOR

Model Number H82

Device Problems Sticking (1597); Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Inflammation (1932); Itching Sensation (1943); Peeling (1999); Fluid Discharge (2686)

Event Date 05/14/2018

Event Type  Injury  

Event Description

I have used the freestyle libre to manage type 1 diabetes since (b)(6) 2017.The initial 12 applications had no adverse reactions.However, a new prescription (lot 180126p, sn (b)(4)) resulted in thickening of the skin and redness upon removing an adhesive patch after a normal 10-day usage.Upon applying a second patch from the same lot to the opposite arm, the reaction was acute after 10 days resulting in a blazing red, raw circle with the exact dimensions as the adhesive patch.Blisters, clear oozing liquid and blood were observed.Several layers of skin were removed when the adhesive patch was taken from my arm.The infected zone itched like poison ivy and remained raw and red until medicines were applied to alleviate inflammation.The adhesive patch zone on the opposite arm from 10 days ago remains thick and pink.

• Brand Name: FREESTYLE LIBRE SENSOR
• Type of Device: FREESTYLE LIBRE GLUCOSE MONITOR
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 7525541
• MDR Text Key: 108806866
• Report Number: MW5077313
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00357599000196
• UDI-Public: (01)00357599000196
• 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: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/30/2018
• Device Model Number: H82
• Device Lot Number: 180126P
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 49