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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
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Swelling (2091); Reaction (2414); Skin Inflammation (2443); Caustic/Chemical Burns (2549)
Event Date 02/01/2019
Event Type  malfunction  
Event Description
Reporter called to report that she has been using freestyle libre sensor for over a year and in (b)(6) starting with the last of three in her lot; she developed chemical burns, skin inflammation, itching and blisters underneath her sensor. She reports that she cannot wear it more than three days and it's supposed to last 10 days. "i placed a sensor on (b)(6); the area underneath the sensor is just starting to heal. " report states that she had a difficult time reaching abbott once she did she spoke to mr schantter the tech director for abbott diabetes care, and she explained to him what was happening to her, and sent him pictures. The abbott rep told her that he never heard of this happening and that changes have been made to the adhesive on the 14 day sensor. He later made a correction and told the reporter that the 10 day sensor adhesive may have been change too due to the device not adhering. The reporter asked since she is having a reaction to the stronger adhesive on sensor, if abbott could supply her some test strips for free and abbott rep declined to send her anything. Reporter states that her insurance does not cover glucose test strips.
 
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Brand NameFREESTYLE LIBRE
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key8487264
MDR Text Key141166776
Report NumberMW5085608
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 04/04/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received04/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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: 04/04/2019 Patient Sequence Number: 1
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