BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE 2 PLUS

    MDR report key: 24756524 · Received April 1, 2026

    Report

    Report Number
    2954323-2026-20221
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 4, 2026
    Report Date
    May 22, 2026
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QBJ
    UDI-DI
    05021791006946
    PMA / PMN Number
    K223435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SENSOR (B)(6) HAS BEEN RETURNED AND INVESTIGATED. THE SENSOR PLUG IS FULLY SEATED AND NO ISSUES WERE OBSERVED ON THE SENSOR PATCH. EXTRACTED DATA FROM THE RETURNED SENSOR USING APPROVED SOFTWARE. SENSOR STATE 6 WITH EVENT LOGS 6 AND 7 ARE AN INDICATION THAT THE PATCH WAS TERMINATED WITHOUT ANY ERROR. THE EVENT LOGS OBSERVED ARE CONSISTENT WITH NORMAL TERMINATION AND INDICATE THE SENSOR HAS REACHED ITS END OF LIFE. VISUAL INSPECTION HAS BEEN PERFORMED ON THE SENSOR PLUG ASSEMBLY; NO FAILURE MODES WERE OBSERVED. PERFORMED SMU (SOURCE MEASUREMENT UNIT) TEST TO ENSURE THE SENSOR'S ELECTRONICS WERE FUNCTIONING CORRECTLY AND THE RETURNED UNIT DID NOT HAVE ANY GLUCOSE READING ISSUES. 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. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    REPEATED ATTEMPTS BY ADC TO RETRIEVE THE PRODUCT WERE UNSUCCESSFUL AND/OR THE CUSTOMER DISCARDED THE PRODUCT. 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. AT THIS TIME, THE PRODUCT HAS NOT YET BEEN RETURNED FOR THIS COMPLAINT. 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. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT WILL BE SUBMITTED. 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 69.00 MG/DL COMPARED TO READINGS OF 194.00 MG/DL RESPECTIVELY OBTAINED ON A METER AND THE RESULTS, WHEN PLOTTED ON A PARKES ERROR GRID, FALL INTO THE C ZONE, SHOWING DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THE LENGTH OF SENSOR WEAR WAS UNKNOWN. 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 69.00 MG/DL COMPARED TO READINGS OF 194.00 MG/DL RESPECTIVELY OBTAINED ON A METER AND THE RESULTS, WHEN PLOTTED ON A PARKES ERROR GRID, FALL INTO THE C ZONE, SHOWING DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THE LENGTH OF SENSOR WEAR WAS UNKNOWN. 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
    470780 FREESTYLE LIBRE 2 PLUS FLASH GLUCOSE MONITORING SYSTEM QBJ ABBOTT DIABETES CARE INC 78747-01 05021791006946

    Patients

    Seq Age Sex Outcome Treatment
    1