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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, GLUCOSE, INVASIVE

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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14 DAY SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number NDC 57599-0001-01
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Skin Irritation (2076); Ulceration (2116)
Event Date 04/04/2020
Event Type  Injury  
Event Description
An abbott freestyle libre 14 day sensor was dispensed to me at my local (b)(6). The initial sensor i applied on my right arm, i ended up with blister. Therefore, i waited for a few weeks, followed the instructions and applied a brand new sensor on my left arm. In less than three (3) days. I began notice fluid flowing underneath the sensor. When i removed the sensor there was huge wound. Which took about two weeks of treatment before healing. I have reached out to abbott a few times to report the adverse event and never got a respond from the company. I have pictures to show with regards to the wound. Fda safety report id# (b)(4).
 
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Brand NameFREESTYLE LIBRE 14 DAY
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key10442257
MDR Text Key204200048
Report NumberMW5096193
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00357599001018
UDI-Public357599001018
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 08/19/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Model NumberNDC 57599-0001-01
Device Catalogue Number3 57599 00101 8
Device Lot Number200504R
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?
Type of Device Usage

Patient Treatment Data
Date Received: 08/21/2020 Patient Sequence Number: 1
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