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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE, INC. FREE STYLE LIBRE CONTINUOUS GLUCOSE MONITOR 14 DAY SENSOR SENSOR, GLUCOSE, INVASIVE

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ABBOTT DIABETES CARE, INC. FREE STYLE LIBRE CONTINUOUS GLUCOSE MONITOR 14 DAY SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problems Loss of or Failure to Bond (1068); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/23/2019
Event Type  malfunction  
Event Description
The accuracy and reliability of the free style libre 14 day sensor is suspect especially after 10 days. I have noticed the scan reading and the finger stick reading can be up to 80 units off. I have seen it from 2 days after applying to 10 days after applying before the discrepancies. The company only offers a replacement. Typically i have taken the finger stick and compared to screen readings when the screen reading show a steady level. Not all sensors failed but a majority of them do. Also, my skin does not allow for the sensor to stay on especially when humid and i am working outdoors. Based on the scan readings, i do not take medicine which shows high a1cs. Fda safety report id# (b)(4).
 
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Brand NameFREE STYLE LIBRE CONTINUOUS GLUCOSE MONITOR 14 DAY SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE, INC.
MDR Report Key9150962
MDR Text Key161370994
Report NumberMW5090190
Device Sequence Number1
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
Type of Report Initial
Report Date 10/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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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