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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 Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Markings/Labelling Problem (2911)
Patient Problems Erythema (1840); Itching Sensation (1943); Pain (1994); Scarring (2061); Swelling (2091); Tissue Damage (2104); Reaction (2414); Fluid Discharge (2686)
Event Date 03/16/2019
Event Type  Injury  
Event Description
Began using the freestyle libre 14 day system and developed a severe allergic skin reaction to the adhesive. Abbott refuses to provide users with a list of "ingredients" is the adhesive in order to determine what we are allergic to my skin reaction consists of redness and itching, then progresses to blisters which then leads to oozing of a large amount of serous fluid from the affected skin as well as several layers of skin sloughing off where the sensor adhesive made contact. This has lead to permanent scarring, it's incredibly painful for about a week until the skin heals (which being a diabetic is a problem to begin with). I've also had several inaccurate readings differing from 20-60 points different from my blood sugar via my glucometer. This had lead to unnecessary treatments and trying to correct a blood sugar that was fine to begin with. There should be a way to calibrate the libre sensor. 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 Key8500497
MDR Text Key141647679
Report NumberMW5085732
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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: 04/09/2019 Patient Sequence Number: 1
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