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U.S. Department of Health and Human Services

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

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ABBOTT LABORATORIES / ABBOTT DIABETES CARE INC. LIBRE FREESTYLE 14 DAY SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number 229
Device Problems Loss of or Failure to Bond (1068); Device Fell (4014)
Patient Problems Swelling (2091); Caustic/Chemical Burns (2549)
Event Date 08/21/2019
Event Type  malfunction  
Event Description
The freestyle libre sensors do not reliably stay adhered to the skin after applied. I have contacted the mfr on several occasions. They recommended an add'l adhesive, which i tried, but i got chemical burns and blisters from the adhesive so i stopped using it. The sensors fall off after 5-6 days on both the 10 day sensors (which are now discontinued) and the 14 day sensor. I am spending a lot of money to monitor my glucose and the devices are not reliable that they will work when needed. Fda safety report id# (b)(4).
 
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Brand NameLIBRE FREESTYLE 14 DAY SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT LABORATORIES / ABBOTT DIABETES CARE INC.
MDR Report Key8931250
MDR Text Key155694146
Report NumberMW5089310
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 Patient
Type of Report Initial
Report Date 08/21/2019
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received08/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number229
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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