BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 2

    MDR report key: 19681260 · Received July 5, 2024

    Report

    Report Number
    2954323-2024-23955
    Event Type
    Injury
    Date Received
    July 5, 2024
    Date of Event
    June 13, 2024
    Report Date
    July 5, 2024
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    UDI-DI
    00357599800000
    PMA / PMN Number
    K193371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. SENSOR WAS FOUND TO BE IN STATE 3 (INDICATING PAIRED STATE: SENSOR WORKS IN THIS STATE ALL 14 DAYS). REMOVED THE SENSOR PLUG AND INSPECTED THE PLUG ASSEMBLY, NO FAILURE MODE OBSERVED. SENSOR WAS REPROGRAMMED AND SIMVIVO TEST PERFORMED. ALL RESULTS WERE WITHIN SPECIFICATION. POISE VOLTAGE AND SENSOR THERMISTOR TESTING WERE BOTH WITHIN SPECIFICATION, INDICATING THE SENSOR WAS PROVIDING ACCURATE GLUCOSE READINGS. 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

    A REPLACE SENSOR ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE AND CUSTOMER WAS UNABLE TO OBTAIN READINGS. AS A RESULT, CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT, REQUIRING THIRD-PARTY ADMINISTRATION OF ¿SUGAR¿ INJECTION AND INSULIN (UNSPECIFIED) FROM A HEALTHCARE PROFESSIONAL FOR A HYPOGLYCEMIA DIAGNOSIS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466519 FREESTYLE LIBRE 2 FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71992-01 00357599800000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention