BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3 PLUS

    MDR report key: 24546791 · Received March 9, 2026

    Report

    Report Number
    2954323-2026-12834
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    February 21, 2026
    Report Date
    March 9, 2026
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QBJ
    UDI-DI
    05021791007226
    PMA / PMN Number
    K223435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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 PRODUCT WERE REVIEWED AND THE DHRS SHOWED THE PRODUCT 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, MITIGATIONS 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. 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 THE CUSTOMER WAS UNABLE TO OBTAIN GLUCOSE READINGS. AS A RESULT, THE CUSTOMER EXPERIENCED SYMPTOMS, SUCH AS CONFUSION, DIZZINESS, AND A POSSIBLE LOSS OF CONSCIOUSNESS. LATER ON, THE CUSTOMER WAS CAPABLE TO SELF-TREATING BY EATING CHOCOLATE. ADC CUSTOMER SERVICE ATTEMPTED TO CONTACT THE CUSTOMER TO GAIN ADDITIONAL DETAILS REGARDING THIS EVENT; IT IS CERTAIN THAT THE CUSTOMER HAD FALLEN, POSSIBLY HIT THEIR HEAD, OR POSSIBLY LOST CONSCIOUSNESS. THE CUSTOMER WAS PROVIDED THE FOLLOWING MEDICATIONS PRESCRIBED BY A HEALTHCARE PROFESSIONAL: "NORSBAN 5 MG / 10 MG, OMNIC OCAS 0.4 MG, PICORION 5 MG, KROSUVASTATIN / EZETIMIBE KRKA 20/10 MG, TADALAFIL 5 MG, E-KALCOR 400 IU, LOSATREX 12.5 MG, MGONCOR CKF, ATSONA 50 MG, UDOPION ORION 150 MG, AND KETIPI." IN ADDITION, THE CUSTOMER SCHEDULED A DOCTOR'S APPOINTMENT A FEW DAYS LATER, AND THE CUSTOMER PERFORMED A GLUCOSE TEST AND X-RAY SCAN. THE DOCTOR PROVIDED A WHEELCHAIR DUE TO BROKEN BONES IN THE CUSTOMER'S FEET. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613022 FREESTYLE LIBRE 3 PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM QBJ ABBOTT DIABETES CARE INC 78768-01 05021791007226

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention