BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 2

    MDR report key: 12502820 · Received September 20, 2021

    Report

    Report Number
    2954323-2021-85084
    Event Type
    Injury
    Date Received
    September 20, 2021
    Date of Event
    August 29, 2021
    Report Date
    September 20, 2021
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    PMA / PMN Number
    K193371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PRODUCT IS NOT EXPECTED TO BE RETURNED AS THE DEVICE WAS REPORTEDLY DISCARDED. 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. DHRS (DEVICE HISTORY RECORD) 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. IN THE EVENT THAT UNANTICIPATED PRODUCT IS RECEIVED, A PHYSICAL INVESTIGATION WILL BE PERFORMED PER ADC'S ESTABLISHED PROCESSES AND PROCEDURES AND A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A CAREGIVER REPORTED THE CUSTOMER EXPERIENCED A SKIN REACTION AT THE SITE OF THE FREESTYLE LIBRE 2 SENSOR. THE CUSTOMER EXPERIENCED PUS AND PAIN AT SENSOR SITE, AND WAS PRESCRIBED ANTIBIOTIC OINTMENT LIADE 15 G BY A HEALTHCARE PROVIDER FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397828 FREESTYLE LIBRE 2 FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71992-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention