BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 2

    MDR report key: 20125449 · Received September 3, 2024

    Report

    Report Number
    2954323-2024-33943
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    August 22, 2024
    Report Date
    September 3, 2024
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    UDI-DI
    05021791002504
    PMA / PMN Number
    K193371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION AND THE CUSTOMER AGREED TO RETURN THE DEVICE; HOWEVER, AT THIS TIME PRODUCT HAS NOT YET BEEN RECEIVED. AN 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 FREESTYLE LIBRE SENSOR AND FREESTYLE LIBRE SENSOR KIT WERE REVIEWED AND THE DHRS SHOWED THE FREESTYLE LIBRE SENSOR AND SENSOR KIT PASSED ALL TESTS PRIOR TO RELEASE. THE MOST PROBABLE ROOT CAUSES ASSOCIATED WITH THIS FAILURE MODE ARE DISCONNECTED, FAULTY OR DAMAGED COMPONENTS, SOFTWARE/DATA CORRUPTION, OR MISUSE. HOWEVER, MITIGATION'S ARE IN PLACE TO REDUCE AND PREVENT SUCH ISSUES. ALL VITAL MANUFACTURING STEPS ARE VALIDATED, MONITORED, AND VERIFIED DURING MANUFACTURING TO ENSURE THE SYSTEM IS IN CONFORMANCE WITH THE VERIFIED DESIGN. ALL VITAL FUNCTIONS ARE MONITORED BY THE SYSTEM AND, WHEN NECESSARY, FUNCTION IS SUSPENDED TO SAFEGUARD AGAINST INACCURATE RESULTS. LABELING IS PROVIDED TO INSTRUCT THE USER ON THE INTENDED USE OF ALL VITAL PARTS OF THE SYSTEM TO MINIMIZE MISUSE. ALL COMPLAINTS AND COMPLAINT TRENDS ARE INVESTIGATED TO DETERMINE IF THERE IS A PRODUCT DEFECT/ DEFICIENCY. IF A PRODUCT DEFECT/ DEFICIENCY IS IDENTIFIED, A RISK EVALUATION IS COMPLETED AND COMPARED TO THE RISK MANAGEMENT REPORT, TO ENSURE THE RISK PROFILE HAS NOT CHANGED. ADDITIONALLY, AS A PART OF ABBOTT¿S POST-MARKET SURVEILLANCE PROCESS, ALL RISK EVALUATIONS WITH ASSOCIATED COMPLAINT DATA ARE REVIEWED ANNUALLY TO DETERMINE IF THE RISK PROFILES HAVE CHANGED AS COMPARED TO THE PRODUCT RISK MANAGEMENT REPORTS. THESE MONITORING PROCESSES ENSURE THAT ALL PRODUCT RISK PROFILES REMAIN ACCEPTABLE AND HAVE A POSITIVE BENEFIT/ RISK RATIO. IF PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED PER ADC'S ESTABLISHED PROCESSES AND PROCEDURES AND A REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION. THE DATE OF EVENT IS UNKNOWN. THE DATE ENTERED IN SECTION B3 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED VIA EMAIL. A "REPLACE SENSOR" ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE AND THE CUSTOMER WAS UNABLE TO OBTAIN GLUCOSE READINGS. AS A RESULT, THE CUSTOMER EXPERIENCED CONVULSIONS AND WAS ABLE TO SELF-TREAT WITH "1WW". THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701179 FREESTYLE LIBRE 2 FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71992-01 05021791002504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other