BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 19893208 · Received August 2, 2024

    Report

    Report Number
    2954323-2024-28259
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    July 19, 2024
    Report Date
    August 22, 2024
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QLG
    PMA / PMN Number
    K223435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DEVICE MANUFACTURING 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.

    Additional Manufacturer Narrative · 0

    REPEATED ATTEMPTS BY ADC TO RETRIEVE THE PRODUCT WERE UNSUCCESSFUL AND/OR THE CUSTOMER DISCARDED THE PRODUCT. THE MOST PROBABLE ROOT CAUSES ASSOCIATED WITH THIS INCIDENT ARE THE ADHESIVE, INCLUDING THE ADHESIVE IRRITATING THE USER¿S SKIN, OR MISUSE, INCLUDING IMPROPER SITE SELECTION AND REPEATEDLY USING THE SAME APPLICATION SITE TO PLACE THE SENSOR. THESE CONDITIONS ARE MITIGATED THROUGH THE FREESTYLE PRODUCT LABELLING. ALL COMPLAINTS AND COMPLAINT TRENDS ARE INVESTIGATED TO DETERMINE IF THERE IS A PRODUCT DEFECT/ DEFICIENCY. IF A PRODUCT DEFECT/ DEFICIENCY IS IDENTIFIED, A RISK EVALUATION IS COMPLETED AND COMPARED TO THE RISK MANAGEMENT REPORT, TO ENSURE THE RISK PROFILE HAS NOT CHANGED. ADDITIONALLY, AS A PART OF ABBOTT¿S POST-MARKET SURVEILLANCE PROCESS, ALL RISK EVALUATIONS WITH ASSOCIATED COMPLAINT DATA ARE REVIEWED ANNUALLY TO DETERMINE IF THE RISK PROFILES HAVE CHANGED AS COMPARED TO THE PRODUCT RISK MANAGEMENT REPORTS. THESE MONITORING PROCESSES ENSURE THAT ALL PRODUCT RISK PROFILES REMAIN ACCEPTABLE AND HAVE A POSITIVE BENEFIT/ RISK RATIO. AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED. 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. 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. 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. IF PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED PER ADC'S ESTABLISHED PROCESSES AND PROCEDURES AND A REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A PERCEIVED ADVERSE SKIN REACTION WAS REPORTED WITH WEAR OF THE ABBOTT DIABETES CARE (ADC) DEVICE. FURTHERMORE, THE CUSTOMER EXPERIENCED SYMPTOMS OF INFECTION AT SENSOR SITE DESCRIBED AS AN ABSCESS THAT REQUIRED CONTACT WITH A HEALTHCARE PROFESSIONAL (HCP) IN THE EMERGENCY ROOM WHO ¿CUT OPEN¿ THE ABSCESS INITIALLY AND THEN PRESCRIBED PVP-JOD AL OINTMENT 25G FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A PERCEIVED ADVERSE SKIN REACTION WAS REPORTED WITH WEAR OF THE ABBOTT DIABETES CARE (ADC) DEVICE. FURTHERMORE, THE CUSTOMER EXPERIENCED SYMPTOMS OF INFECTION AT SENSOR SITE DESCRIBED AS AN ABSCESS THAT REQUIRED CONTACT WITH A HEALTHCARE PROFESSIONAL (HCP) IN THE EMERGENCY ROOM WHO ¿CUT OPEN¿ THE ABSCESS INITIALLY AND THEN PRESCRIBED PVP-JOD AL OINTMENT 25G FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885572 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE LTD 72081-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention