BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 24780512 · Received April 3, 2026

    Report

    Report Number
    2954323-2026-21829
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    December 26, 2025
    Report Date
    May 9, 2026
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QBJ
    PMA / PMN Number
    K223435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PHYSICAL INVESTIGATION OF PRODUCT IS NOT ANTICIPATED AS REPORTER INDICATED DEVICE WAS DISCARDED. INVESTIGATION WILL BE PERFORMED PER ADC'S ESTABLISHED PROCESSES AND PROCEDURES, AND A REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION ACTIVITIES. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE REPORTED PRODUCT IS NOT EXPECTED TO BE RETURNED AS REPORTER INDICATED THE DEVICE WAS DISCARDED. THEREFORE, NO FURTHER INVESTIGATION IS PLANNED. IN THE EVENT THAT PRODUCT IS RECEIVED, A PHYSICAL INVESTIGATION WILL BE PERFORMED PER ADC'S ESTABLISHED PROCESSES AND PROCEDURES AND A REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION. 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. A VALID SERIAL NUMBER HAS NOT BEEN PROVIDED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. CLINICAL DATA WAS REVIEWED AND CONFIRMED THAT LIBRE SENSORS CONTINUE TO BE SAFE, EFFECTIVE, AND PERFORM AS INTENDED IN THE FIELD. STABILITY DATA FOR LIBRE SENSORS WAS REVIEWED AND SHOWED NO ANOMALIES OR NON-CONFORMANCES THAT COULD HAVE LEAD TO THE COMPLAINT. TRACKING AND TRENDING REPORTS FOR THE PAST YEAR WERE REVIEWED BASED ON THE PRODUCT LINE AND REPORTED ISSUE. THE REVIEW IDENTIFIED A TRIPPED TREND, AN INVESTIGATION WAS CONDUCTED, AND CORRECTIVE ACTIONS HAVE BEEN TAKEN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED RECEIVING LOW GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE CUSTOMER RECEIVED SENSOR SCAN RESULTS OF 120 MG/DL COMPARED TO READINGS OF 250 MG/DL RESPECTIVELY OBTAINED ON A COMPETITOR BRAND METER AND THE RESULTS, WHEN PLOTTED ON A PARKES ERROR GRID, FALL INTO THE C ZONE, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THE LENGTH OF SENSOR WEAR WAS 7 DAYS. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED RECEIVING LOW GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE CUSTOMER RECEIVED SENSOR SCAN RESULTS OF 120 MG/DL COMPARED TO READINGS OF 250 MG/DL RESPECTIVELY OBTAINED ON A COMPETITOR BRAND METER AND THE RESULTS, WHEN PLOTTED ON A PARKES ERROR GRID, FALL INTO THE C ZONE, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THE LENGTH OF SENSOR WEAR WAS 7 DAYS. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21691 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QBJ ABBOTT DIABETES CARE LTD 72081-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown