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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
Lot Number G02
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burn(s) (1757); Erythema (1840); Skin Irritation (2076); Swelling (2091); Skin Inflammation (2443)
Event Date 05/08/2020
Event Type  Injury  
Event Description
The freestyle libre sensor has been used for over a year with no problem. Starting sometime in (b)(6), the disk would come off sooner that it should (it lasts 2 weeks before replacement), and underneath the disk, in the exact shape of the disk, was an acid like burn on the skin of the arm. It consisted of bright red, blistered, raised lesions on the skin in the exact circle of the disk. This has happened four times, with four different disks. In calling the company, they said that sometimes they change the adhesive to make it more sticky. Whatever they've changed it to is causing the skin to be greatly compromised. The most recent disk had sn (b)(4) expiring 8-31-2020. The patient has nka and can use any bandaid without issue; no latex allergy. 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 Key10074803
MDR Text Key191816254
Report NumberMW5094574
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 05/15/2020
4 Devices were Involved in the Event: 1   2   3   4  
0 Patients were Involved in the Event:
Date FDA Received05/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Lot NumberG02
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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