BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3 PLUS

    MDR report key: 24958775 · Received April 22, 2026

    Report

    Report Number
    2954323-2026-40263
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    April 13, 2026
    Report Date
    April 22, 2026
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QBJ
    PMA / PMN Number
    K223435
    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. 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.

    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. A TRIPPED TREND REVIEW WAS CONDUCTED FOR THE REPORTED COMPLAINT AND THE PRODUCT; NO TRENDS WERE IDENTIFIED THAT WOULD INDICATE ANY PRODUCT RELATED ISSUES. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A HIGH GLUCOSE READING ISSUE WITH THE ABBOTT DIABETES CARE (ADC) DEVICE WAS REPORTED. THE CUSTOMER RECEIVED UNSPECIFIED HIGHER SENSOR SCAN RESULTS COMPARED TO UNSPECIFIED READINGS OBTAINED ON A COMPETITOR BRAND DEVICE AND CUSTOMER NOTED A VERTICAL TREND ARROW WHICH INDICATES RAPIDLY RISING/DECLINING GLUCOSE LEVELS (MORE THAN 2 MG/DL PER MINUTE). THE CUSTOMER DID NOT EXPERIENCE SYMPTOMS AND SELF-TREATED WITH SUGAR. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT. A SENSOR RESULT OF 440 MG/DL WAS COMPARED TO A COMPETITOR BRAND DEVICE READING OF 80 MG/DL AND THE RESULTS, WHEN PLOTTED ON A PARKES ERROR GRID, FALL INTO THE D ZONE, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THE LENGTH OF SENSOR WEAR IS 1 DAY. IT IS UNKNOWN WHEN THESE READINGS WERE OBTAINED IN RELATION TO THE REPORTED ADVERSE EVENT.

    Description of Event or Problem · 0

    A HIGH GLUCOSE READING ISSUE WITH THE ABBOTT DIABETES CARE (ADC) DEVICE WAS REPORTED. THE CUSTOMER RECEIVED UNSPECIFIED HIGHER SENSOR SCAN RESULTS COMPARED TO UNSPECIFIED READINGS OBTAINED ON A COMPETITOR BRAND DEVICE AND CUSTOMER NOTED A VERTICAL TREND ARROW WHICH INDICATES RAPIDLY RISING/DECLINING GLUCOSE LEVELS (MORE THAN 2 MG/DL PER MINUTE). THE CUSTOMER DID NOT EXPERIENCE SYMPTOMS AND SELF-TREATED WITH SUGAR. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT. A SENSOR RESULT OF 440 MG/DL WAS COMPARED TO A COMPETITOR BRAND DEVICE READING OF 80 MG/DL AND THE RESULTS, WHEN PLOTTED ON A PARKES ERROR GRID, FALL INTO THE D ZONE, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THE LENGTH OF SENSOR WEAR IS 1 DAY. IT IS UNKNOWN WHEN THESE READINGS WERE OBTAINED IN RELATION TO THE REPORTED ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534680 FREESTYLE LIBRE 3 PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM QBJ ABBOTT DIABETES CARE INC 78768-01

    Patients

    Seq Age Sex Outcome Treatment
    1