BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 19342126 · Received May 17, 2024

    Report

    Report Number
    2954323-2024-17293
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    April 16, 2024
    Report Date
    May 17, 2024
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QLJ
    UDI-DI
    30357599818006
    PMA / PMN Number
    K213996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SENSOR (B)(6) HAS BEEN RETURNED AND INVESTIGATED. VISUAL INSPECTION HAS BEEN PERFORMED ON SENSOR AND NO ISSUES WERE OBSERVED. THE SENSOR PLUG WAS SEATED IN MOUNT PROPERLY. DATA WAS SUCCESSFULLY EXTRACTED FROM THE RETURNED SENSOR USING APPROVED SOFTWARE. THE SENSOR WAS FOUND TO BE IN SENSOR STATE 8 (INDICATING NORMAL TERMINATION ON THE BODY). ALL RESULTS WERE WITHIN SPECIFICATION. THEREFORE, THE ISSUE IS NOT CONFIRMED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE DEVICE HISTORY RECORDS (DHRS) 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. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    AN "REPLACE SENSOR" ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE AND THE CUSTOMER WAS UNABLE TO OBTAIN READINGS. AS A RESULT, THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS TREATED BY A NON-HEALTHCARE PROFESSIONAL, THEIR WIFE, WHO GAVE THEM ORANGE JUICE. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904955 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QLJ ABBOTT DIABETES CARE LTD 72081-01 30357599818006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention