BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 24912182 · Received April 17, 2026

    Report

    Report Number
    2954323-2026-34178
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 20, 2026
    Report Date
    April 17, 2026
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QBJ
    PMA / PMN Number
    K223435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    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 55, 134 MG/DL COMPARED TO READINGS OF 173, 191 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 8 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
    973605 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QBJ ABBOTT DIABETES CARE LTD 72081-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown