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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Swelling (2091); Reaction (2414); Skin Inflammation (2443); Caustic/Chemical Burns (2549)

Event Date 02/01/2019

Event Type  malfunction  

Event Description

Reporter called to report that she has been using freestyle libre sensor for over a year and in (b)(6) starting with the last of three in her lot; she developed chemical burns, skin inflammation, itching and blisters underneath her sensor.She reports that she cannot wear it more than three days and it's supposed to last 10 days."i placed a sensor on (b)(6); the area underneath the sensor is just starting to heal." report states that she had a difficult time reaching abbott once she did she spoke to mr schantter the tech director for abbott diabetes care, and she explained to him what was happening to her, and sent him pictures.The abbott rep told her that he never heard of this happening and that changes have been made to the adhesive on the 14 day sensor.He later made a correction and told the reporter that the 10 day sensor adhesive may have been change too due to the device not adhering.The reporter asked since she is having a reaction to the stronger adhesive on sensor, if abbott could supply her some test strips for free and abbott rep declined to send her anything.Reporter states that her insurance does not cover glucose test strips.

• Brand Name: FREESTYLE LIBRE
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 8487264
• MDR Text Key: 141166776
• Report Number: MW5085608
• 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: 04/04/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 70