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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE, INC. ABBOTT FREESTYLE LIBRE GLUCOSE MONITORING SYSTEM SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number READER S/N JNGY356-K0097
Device Problems Incorrect, Inadequate or Imprecise Resultor 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).
 
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Brand NameABBOTT FREESTYLE LIBRE GLUCOSE MONITORING SYSTEM
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE, INC.
MDR Report Key9595926
MDR Text Key175834374
Report NumberMW5092268
Device Sequence Number3
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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  
0 Patients were Involved in the Event:
Date FDA Received01/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberREADER S/N JNGY356-K0097
Device Catalogue NumberREADER VERSION 2.4.4 1.00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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