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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD. FREESTYLE LIBRE 14-DAY GLUCOSE SENSOR SENSOR, GLUCOSE, INVASIVE

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ABBOTT DIABETES CARE LTD. FREESTYLE LIBRE 14-DAY GLUCOSE SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Inflammation (1932); Itching Sensation (1943); Swelling (2091)
Event Date 03/15/2019
Event Type  Injury  
Event Description
The free style libre 14-day glucose system sensor adhesive caused significant reaction on my skin that took weeks to clear. The sensor was applied following the directions, including clearing with an alcohol wipe, itching, blistering, redness, and swelling resulted. After a couple of weeks i tried to apply another sensor on the other arm and got the same result. Fda safety report id# (b)(4).
 
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Brand NameFREESTYLE LIBRE 14-DAY GLUCOSE SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE LTD.
MDR Report Key8591181
MDR Text Key144532275
Report NumberMW5086449
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 05/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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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