• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT DIABETES CARE INC. FREESTYLE LIBRE SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burn(s) (1757); Unspecified Infection (1930); Rash (2033); Scarring (2061); Impaired Healing (2378)
Event Date 10/01/2019
Event Type  Injury  
Event Description
Contact dermatitis burns; after applying the freestyle libre sensor for 14 days i noticed a rash started to appear around the injection site as well as the adhesive was stuck. Because i am a type 1 diabetic i cannot go without a way to check my blood sugar at a continuous rate kept applying and the rash turned into a burn that left blisters and scarring. I heal very slowly and the risk of infection is extremely high due to my diabetes. I reached out to the pharmaceutical company, abbott laboratories, for info regarding the ingredients in the adhesive used on the libre sensor and they refused to give me the info. These continuous glucose monitoring systems are not cheap and it's life or death for me when it comes to getting my insulin and how much i give based on my blood sugar readings. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFREESTYLE LIBRE SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key9641765
MDR Text Key177157385
Report NumberMW5092592
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 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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: 01/28/2020 Patient Sequence Number: 1
-
-