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

Model Number 229

Device Problems Loss of or Failure to Bond (1068); Device Fell (4014)

Patient Problems Swelling (2091); Caustic/Chemical Burns (2549)

Event Date 08/21/2019

Event Type  malfunction  

Event Description

The freestyle libre sensors do not reliably stay adhered to the skin after applied.I have contacted the mfr on several occasions.They recommended an add'l adhesive, which i tried, but i got chemical burns and blisters from the adhesive so i stopped using it.The sensors fall off after 5-6 days on both the 10 day sensors (which are now discontinued) and the 14 day sensor.I am spending a lot of money to monitor my glucose and the devices are not reliable that they will work when needed.Fda safety report id# (b)(4).

• Brand Name: LIBRE FREESTYLE 14 DAY SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT LABORATORIES / ABBOTT DIABETES CARE INC.
• MDR Report Key: 8931250
• MDR Text Key: 155694146
• Report Number: MW5089310
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00357599000042
• UDI-Public: (01)00357599000042(10)2.2.1.4521
• 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: 08/21/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 229
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 109