BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE 2

    MDR report key: 25113296 · Received May 7, 2026

    Report

    Report Number
    2954323-2026-67626
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 7, 2026
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    UDI-DI
    05021791002504
    PMA / PMN Number
    K193371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION ACTIVITIES OR IF ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SENSOR (B)(6) HAS BEEN RETURNED AND INVESTIGATED. THE SENSOR PLUG IS FULLY SEATED AND NO ISSUES WERE OBSERVED. EXTRACTED DATA FROM THE RETURNED SENSOR USING APPROVED SOFTWARE. THE SENSOR WAS FOUND TO BE IN SENSOR STATE 5 (INDICATING NORMAL TERMINATION). SENSOR STATE 5 WITH EVENT LOGS 3 AND 4 ARE AN INDICATION OF NORMAL TERMINATION OF THE SENSOR WITHOUT ANY ERROR. VISUAL INSPECTION HAS BEEN PERFORMED ON THE SENSOR PLUG ASSEMBLY, NO FAILURE MODES WERE OBSERVED. THE CURRENT WAS APPLIED TO THE SENSOR TO PERFORM ACCURACY TESTING WHILE IN THE TEST FIXTURE. ALL RESULTS WERE WITHIN SPECIFICATION. POISE VOLTAGE AND SENSOR THERMISTOR TESTING WERE BOTH WITHIN SPECIFICATION, INDICATING THE SENSOR WAS PROVIDING ACCURATE GLUCOSE READINGS. THE PASSING OF FUNCTIONALITY TESTING IS AN INDICATION THAT THERE WERE NO ISSUES WITH SENSOR FUNCTIONALITY AND ELECTRONICS, THEREFORE THIS 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. DHRS (DEVICE HISTORY REVIEW) FOR THE LIBRE SENSOR AND SENSOR KIT WAS REVIEWED AND THE DHRS SHOWED THE LIBRE SENSOR AND SENSOR KIT MET SPECIFICATIONS PRIOR TO RELEASE TO DISTRIBUTION. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE CUSTOMER RECEIVED SENSOR SCAN RESULTS OF 220, 501 MG/DL COMPARED TO READINGS OF 113,130 MG/DL RESPECTIVELY OBTAINED ON A 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 1 DAY. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE CUSTOMER RECEIVED SENSOR SCAN RESULTS OF 322.00 MG/DL 220.00MG/DL, 501.00 MG/DL COMPARED TO READINGS OF 178.00 MG/DL 113.00 MG/DL,130.00 MG/DL RESPECTIVELY OBTAINED ON A 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 1 DAY. 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
    115597 FREESTYLE LIBRE 2 FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71992-01 05021791002504

    Patients

    Seq Age Sex Outcome Treatment
    1