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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 10-DAY SENSOR SENSOR, GLUCOSE, INVASIVE

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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 10-DAY SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Overheating of Device (1437)
Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Event Date 12/05/2018
Event Type  Injury  
Event Description
Reaction to freestyle libre 10-day sensor. Looks like a 2nd/3rd degree burn. This was my 4th and 5th sensor. Can supply pictures. Did the problem stop after the person reduced the dose or stopped taking or using the product? yes; did the problem return if the person started taking or using the product again? yes. Reason for use: diabetes, for glucose monitoring.
 
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Brand NameFREESTYLE LIBRE 10-DAY SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key8138466
MDR Text Key129507035
Report NumberMW5081866
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 12/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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

Patient Treatment Data
Date Received: 12/06/2018 Patient Sequence Number: 1
Treatment
ATORVASTATIN ; JANUMET XR; LOSARTAN ; ONE A DAY WOMEN'S; TRULICITY
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