BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 2

    MDR report key: 17267899 · Received July 6, 2023

    Report

    Report Number
    2954323-2023-29034
    Event Type
    Injury
    Date Received
    July 6, 2023
    Date of Event
    June 27, 2023
    Report Date
    July 19, 2023
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    PMA / PMN Number
    K193371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 DATE OF EVENT IS UNKNOWN. THE DATE ENTERED IN SECTION B3 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. 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. NO PRODUCT HAS BEEN RETURNED AND 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 REVIEW) FOR THE FREESTYLE LIBRE SENSOR KIT WERE REVIEWED AND THE DHRS SHOWED THE 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 ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A CUSTOMER EXPERIENCED A SKIN REACTION WHILE WEARING AN ADC DEVICE AND EXPERIENCED SKIN IRRITATION AT THE SENSOR SITE. CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL AND WAS PRESCRIBED DERMIQUE CREAM FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A CUSTOMER EXPERIENCED A SKIN REACTION WHILE WEARING AN ADC DEVICE AND EXPERIENCED SKIN IRRITATION AT THE SENSOR SITE. CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL AND WAS PRESCRIBED DERMIQUE CREAM 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
    418557 FREESTYLE LIBRE 2 FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71992-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention