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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE 14 DAY BLOOD GLUCOSE MONITOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Skin Irritation (2076); Swelling (2091)
Event Date 01/15/2020
Event Type  Injury  
Event Description
Reaction to adhesive used on freestyle libre 14 day blood glucose device. Skin under device was blistered and red. Took approx 2 weeks to heal. Left circular red area which is slowly resolving. Fda safety report id# (b)(4).
 
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Brand NameFREESTYLE LIBRE 14 DAY BLOOD GLUCOSE MONITOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE, INC.
MDR Report Key9711351
MDR Text Key179785192
Report NumberMW5092998
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 02/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/13/2020
Is this an Adverse Event Report? Yes
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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