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

Model Number READER S/N JNGY356-K0097

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

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

Event Date 01/13/2020

Event Type  malfunction  

Event Description

I have been using the abbot freestyle libre monitoring system for 8 months, i have had six of sixteen sensors that were dangerously inaccurate.The readings from my current device have been from 35% to 142% higher than simultaneously recorders done by fingerstick with abbot¿s freestyle lite test strip system.Dosing myself with insulin based on these inaccurate readings could have resulted in harm (low serum glucose) but have not done so as i have carefully checked a finger stick when i had reason to believe the libre system was erroneous.I have a spreadsheet crafted over the past 5 days with about 20 such readings that are all greatly above the finger stick readings.I am a retired physician, so perhaps i am more capable of discovering this problem than the average patient.How many patients out there sense that there is something not right but are unable to accurately determine the cause.How many are overmedicating or undermedicating themselves because of inaccuracies with this device.This is something that the fda should be concerned about and look into the matter.Example: libre 120 lite 89 %variance 35%; libre 84 lite 50 % variance 68%; libre 155 lite 64 % variance 142%.Fda safety report id # (b)(4).

• Brand Name: ABBOTT FREESTYLE LIBRE GLUCOSE MONITORING SYSTEM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC.
• MDR Report Key: 9595926
• MDR Text Key: 175834374
• Report Number: MW5092268
• 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: 01/13/2020
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2020
• Device Model Number: READER S/N JNGY356-K0097
• Device Catalogue Number: READER VERSION 2.4.4 1.00
• Device Lot Number: SENSOR LOT NO. 191101P
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 98