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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 72081-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Itching Sensation (1943); Skin Infection (4544); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Event Date 12/27/2022
Event Type  Injury  
Event Description
A customer reported a skin reaction with the adc device.The customer experienced symptoms of itching, swelling, bleeding, and pus at the placement site.The customer had contact with a healthcare professional who prescribed cortisone ointment, betamethasone ointment, and fucidin cream.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
At this time product has not yet been returned.An extended investigation has been performed for the reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.Dhrs (device history review) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle libre sensor kit passed all tests prior to release.Dose audit reports were reviewed and demonstrates the continued effectiveness of the established sterilization process for libre sensor products.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.If the product is returned, a physical investigation will be performed and a follow-up report submitted.N/a was selected as it is unknown if the user was using android, ios, or a reader with a fs libre 3 sensor.All pertinent information available to abbott diabetes care has been submitted.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.Visual inspection has been performed on the returned sensor patch and no issues were observed.Visual inspection has been performed on the returned sensor adhesive and no issues were observed.No malfunction or product deficiency was identified.Therefore, this issue is not confirmed.Shelf life studies, product monitoring, and dose audits were performed during product development and on market performance continues to be monitored at adc.All pertinent information available to abbott diabetes care has been submitted.This also serves as a correction report.Section h-10 was incorrectly documented in the previous initial report with the following investigation.Please note that section h-10 has been updated with the corrected extended investigation.Dose audit reports were reviewed and demonstrates the continued effectiveness of the established sterilization process for libre sensor products.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.
 
Event Description
A customer reported a skin reaction with the adc device.The customer experienced symptoms of itching, swelling, bleeding, and pus at the placement site.The customer had contact with a healthcare professional who prescribed cortisone ointment, betamethasone ointment, and fucidin cream.There was no report of death or permanent injury associated with this event.
 
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Brand Name
FREESTYLE LIBRE 3
Type of Device
CONTINUOUS GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE LTD
range road
witney 12345 -700
UK  12345-7001
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key16205981
MDR Text Key307699891
Report Number2954323-2023-03284
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/24/2023
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? No
Device Operator Lay User/Patient
Device Expiration Date02/28/2023
Device Model Number72081-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 12/28/2022
Initial Date FDA Received01/19/2023
Supplement Dates Manufacturer Received01/27/2023
Supplement Dates FDA Received02/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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