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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 Erythema (1840); Skin Infection (4544); Swelling/ Edema (4577)
Event Date 08/10/2023
Event Type  Injury  
Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported experiencing a skin reaction while wearing the adc device.The customer experienced symptoms described as swelling, reddening, and infection at the insertion site.The customer had contact with a healthcare professional and received medical treatment however, details of the treatment were not provided.No further information was provided.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.The dhrs (device history review) for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and 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 kits.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.Sensor (b)(6) has been returned and investigated.No physical damage was observed on the returned sensor patch and no issues were observed with the returned sensor adhesive.No malfunction or product deficiency has been identified.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported experiencing a skin reaction while wearing the adc device.The customer experienced symptoms described as swelling, reddening, and infection at the insertion site.The customer had contact with a healthcare professional and received medical treatment however, details of the treatment were not provided.No further information was provided.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 Key17805468
MDR Text Key324108735
Report Number2954323-2023-42057
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K223435
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 10/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date02/29/2024
Device Model Number72081-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received10/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2023
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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