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

Model Number 0M0063EYH94

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2020

Event Type  malfunction  

Event Description

I am a patient that suffer from diabetes and i use the freestyle libre 14 days sensor from abbott laboratories.The problem that i continue having is that after approximately 5 to 6 days of using the sensor it's stop working properly and i have to replace it for a new one before the 14 days.This had happen to me multiple times i have call the company that never receive any resolution or a replacement as they told me i was going to receive."is an excellent product if could work properly, can you please let me know how can help me to resolve this issue." product use: lot 200305p, sn (b)(4).Fda safety report id # (b)(4).

• Brand Name: FREESTYLE LIBRE DAY SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT LABORATORIES/ ABBOTT DIABETES CARE INC.
• MDR Report Key: 10257400
• MDR Text Key: 198501379
• Report Number: MW5095463
• 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: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Model Number: 0M0063EYH94
• Device Lot Number: 200305P
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR