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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE LIMITED FREESTYLE LIBRE 14 DAY SENSOR; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED USER-INITIATED

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ABBOTT DIABETES CARE LIMITED FREESTYLE LIBRE 14 DAY SENSOR; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED USER-INITIATED Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Rash (2033); Burning Sensation (2146)
Event Date 11/23/2019
Event Type  Injury  
Event Description
Started using the freestyle libre in (b)(6) 2019.Worked great no rash.Started developing severe burns / rash / itching under the sensor in (b)(6) 2019.This led to discontinue use and finally removing the adhesive and using a patch over the sensor.This is a great device for something should be done to improve the adhesive there are several online forums / (b)(6) with people having issues.Fda safety report id# (b)(4).
 
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Brand Name
FREESTYLE LIBRE 14 DAY SENSOR
Type of Device
SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED USER-INITIATED
Manufacturer (Section D)
ABBOTT DIABETES CARE LIMITED
MDR Report Key9627174
MDR Text Key176446674
Report NumberMW5092471
Device Sequence Number1
Product Code PZE
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 01/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/31/2020
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/23/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age32 YR
Patient Weight84
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