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

Device Problems Product Quality Problem (1506); Device Slipped (1584)

Patient Problems Purulent Discharge (1812); Irritation (1941); Itching Sensation (1943); Pain (1994); Scarring (2061); Discomfort (2330); Reaction (2414)

Event Date 06/01/2020

Event Type  Injury  

Event Description

Caller reporting on libre sensors that leaves circular scars on her arms.Caller advised she started using sensors from (b)(6) 2019 and was paying (b)(6) for 2 sensors every month.She had no issues until (b)(6) of this year when she experienced irritation, itching, draining of pus, pain and discomfort.Reporter says she alerted the manufacturer and inquired if the needle or adhesive had been changed and was advised an investigation will be conducted and she was going to get a call back.She sent the malfunctioned sensors back to them in a biohazard bag per their request.She has not received a call back as at now.The manufacturer replaced the sensors.This issue has occurred 4 different times and reporter will email pictures of scarred arms from the device.She advised the reaction looks like a chemical burn that peels off skin and makes the sensor fall off.Reporter wants the fda to look into this as she likes the device but can not use it if its going to cause such horrible scarring.

• Brand Name: FREESTYLE LIBRE 14 DAY SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC
• MDR Report Key: 10361818
• MDR Text Key: 201854808
• Report Number: MW5095873
• 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: 08/03/2020
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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 Age: 56 YR
• Patient Weight: 91