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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD. FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM SENSOR SENSOR, GLUCOSE, INVASIVE

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ABBOTT DIABETES CARE LTD. FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Itching Sensation (1943); Rash (2033); Tissue Breakdown (2681)
Event Date 10/02/2018
Event Type  Injury  
Event Description
I use the libre sensors and for the past couple months whenever i put them on, i develop major itching, a rash and blisters. The sensors are supposed to stay on for 14 days, but after 3 days i have to remove it. I've been using a skin barrier to help protect my skin, but whatever is on the sensors to make them stick eats through the barrier. I don't know what is causing this but i still have wound marks left by the sensors. Date the person first started taking or using the product: (b)(6) 2017; to monitor blood sugar levels in type 1 diabetic.
 
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Brand NameFREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE LTD.
MDR Report Key8133324
MDR Text Key129468805
Report NumberMW5081829
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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: 12/04/2018 Patient Sequence Number: 1
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