BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 13980691 · Received April 1, 2022

    Report

    Report Number
    2954323-2022-10830
    Event Type
    Injury
    Date Received
    April 1, 2022
    Date of Event
    March 10, 2022
    Report Date
    April 1, 2022
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QLG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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. SHELF LIFE STUDIES, PRODUCT MONITORING, AND DOSE AUDITS WERE PERFORMED DURING PRODUCT DEVELOPMENT AND ON MARKET PERFORMANCE CONTINUES TO BE MONITORED AT ADC. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, MODEL NUMBER 72114-01, WHICH HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., MODEL NUMBER 71992-01. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED A SKIN REACTION AT THE SITE OF THE ADC DEVICE, WITH SYMPTOMS OF REDNESS, INFLAMMATION, AND SWELLING. THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL WHO PRESCRIBED UNSPECIFIED ANTIBIOTICS 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
    1329594 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE LTD 72114-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention