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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14 DAY GLUCOSE SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number FREESTYLE LIBRE 14 DAY
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Inflammation (1932); Irritation (1941); Partial thickness (Second Degree) Burn (2694)
Event Date 03/20/2020
Event Type  Injury  
Event Description
Blistering and severe irritation at the attachment site of the 14 day freestyle libre glucose sensor. This has been happening since they switched me to the 14 day sensor from the 10 day sensor. I get severe itching while wearing the sensor and then when removed there is a severly irritated, red and inflamed mark that last 5 to 6 weeks after removal of the sensor. 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 INC.
MDR Report Key9877617
MDR Text Key185050547
Report NumberMW5093910
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 03/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Model NumberFREESTYLE LIBRE 14 DAY
Device Catalogue Number71940-01
Device Lot Number191202P
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: 03/24/2020 Patient Sequence Number: 1
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