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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE 14 DAY SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Itching Sensation (1943); Rash (2033); Contact Dermatitis (4546); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/12/2021
Event Type  Injury  
Event Description
Started using the libre 14 days in (b)(6) 2020. No issues with the sensor's adhesive until (b)(6) 2021. The sensor site started itching very badly, and the sensor started to come out before the 14 days were up. There was a bad rash, and pus at the site along with a horrid smell. I switched to my other arm, cleaned it with alcohol, applied a new sensor. After a few days the itching again, really badly. This one made it to the 14 days, but the site again had a nasty, pus covered rash (the rashes take a week or 2 to heal but leave scars). I switched to a new site, and i added a skin-tac barrier before applying my current sensor. After 5 or 6 days it's now itching very badly again, and i just want to rip it out of my arm. I'm suffering bad contact dermatitis due to the sensor's adhesive coating. I'm thinking of stopping use of the libre system all around. Fda safety report id# (b)(4).
 
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Brand NameFREESTYLE LIBRE 14 DAY SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE, INC.
MDR Report Key11495443
MDR Text Key240421329
Report NumberMW5100009
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
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? No
Type of Device Usage

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