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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABTES CARE INC. FREESTYLE LIBRE SENSOR SENSOR, GLUCOSE, INVASIVE

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ABBOTT DIABTES CARE INC. FREESTYLE LIBRE SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Purulent Discharge (1812); Itching Sensation (1943); Impaired Healing (2378); Skin Inflammation (2443)
Event Date 03/01/2019
Event Type  Injury  
Event Description
I have been using the freestyle libre for over a year now with no issues. The last two applications have left a perfectly red circle under the patch which was visible once removed. The area is very itchy, and has taken weeks to heal. It also looked like there could have been some pus on the last removal, and the area is super scaly for weeks now. I do have pictures if requested. If this continues i will have to try a different manufacturer of cgm, or not use this any more.
 
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Brand NameFREESTYLE LIBRE SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABTES CARE INC.
MDR Report Key8456003
MDR Text Key140150250
Report NumberMW5085176
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 03/22/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/26/2019
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: 03/26/2019 Patient Sequence Number: 1
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