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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033); Swelling (2091); Reaction (2414)
Event Date 05/13/2019
Event Type  malfunction  
Event Description
The freestyle libre sensor has caused an allergic reaction that looks very red and dry. I had the sensor on for 4 days and it fell off revealing the red scaly rash. It was incredibly itchy before it fell off. Now there's kinda like swelling up spot around where it was, like a goose egg. I've been using the libre for about 6 months and have had milder reactions, but this one is the worst so far. Allergic reaction / chemical. Fda safety report id# (b)(4).
 
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Brand NameFREESTYLE LIBRE
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE, INC.
MDR Report Key8624706
MDR Text Key145745229
Report NumberMW5086760
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 05/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2019
Is this an Adverse Event Report? No
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

Patient Treatment Data
Date Received: 05/17/2019 Patient Sequence Number: 1
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