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

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

Event Type  malfunction  

Event Description

I was prescribed a free style libre 14 day system in (b)(6) 2021.I used the first sensor on (b)(6).I had no problems with the 1st one.Since then, i have used 14 sensors.Only 4 have given me the 14 days of service.In other words of the 15 sensors i have applied only 33% have performed as advertised.This is a 67% failure rate.Today was the last straw- i applied a new sensor on (b)(6).It quit working on the (b)(6).I applied a new one on the (b)(6).It quit working on the (b)(6).I applied a new one this morning- it never started working at all.So i have applied a new one today (b)(6) 2021 at 1:18 pm.It is currently working but i do not know for how long.It is the last one i had.I have contacted both abbott laboratories and my supplier.I do think that this is a manufacturing problem which needs to be investigated.I am on a fixed income and my co-pay for each sensor is (b)(6) which i can afford but i can not afford (b)(6) a day.Please look into this problem.Thank you.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 14 DAY SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 12861429
• MDR Text Key: 281320854
• Report Number: MW5105517
• 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: 11/18/2021
• 10 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; ATORVASTATIN ; BENEPRIL ; BURPROPION; COMPLETE MULTIVITAMIN ; ENSUCCI; IBUPROFEN ; LANTUS; LEVOTHYROXINE; LEVOTHYROXINE; METFORMIN ; METOPROLOL ; NOVOLOG; TRAMADOL ; TRAXODONE; VITAMIN D
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White