BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3 PLUS

    MDR report key: 24423875 · Received February 23, 2026

    Report

    Report Number
    2954323-2026-10346
    Event Type
    Injury
    Date Received
    February 23, 2026
    Date of Event
    November 30, 2025
    Report Date
    May 5, 2026
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    PMA / PMN Number
    K213996
    Adverse Event
    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 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. 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. 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. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    AN ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH SAMSUNG A 35 5G PHONE WITH ANDROID OPERATING SYSTEM VERSION 3.6.6.12312. THE CUSTOMER RECEIVED AN ERROR MESSAGE AND WAS UNABLE TO OBTAIN GLUCOSE READINGS. AS A RESULT, THE CUSTOMER EXPERIENCED UNSPECIFIED SYMPTOMS OF HYPOGLYCEMIA AND WAS UNABLE TO PROVIDE SELF-TREATMENT RESULTING IN A SEIZURE AND A LOSS OF CONSCIOUSNESS. A GLUCOSE LEVEL OF ¿AROUND 25¿ MG/DL WAS REPORTED USING AN UNKNOWN DEVICE AT THE TIME OF HEALTHCARE PROFESSIONAL (HCP) CONTACT WHO PERFORMED A LAB BLOOD TEST, HOWEVER THE LAB RESULT WERE NOT REPORTED. THE CUSTOMER WAS ADMINISTERED GLUCOSE BY THE HCP FOR THE DIAGNOSIS OF HYPOGLYCEMIA. A LABORATORY RESULT WAS REPORTEDLY OBTAINED BUT THE RESULTS WERE UNSPECIFIED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    AN ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH SAMSUNG A 35 5G PHONE WITH ANDROID OPERATING SYSTEM VERSION 3.6.6.12312. THE CUSTOMER RECEIVED AN ERROR MESSAGE AND WAS UNABLE TO OBTAIN GLUCOSE READINGS. AS A RESULT, THE CUSTOMER EXPERIENCED UNSPECIFIED SYMPTOMS OF HYPOGLYCEMIA AND WAS UNABLE TO PROVIDE SELF-TREATMENT RESULTING IN A SEIZURE AND A LOSS OF CONSCIOUSNESS. A GLUCOSE LEVEL OF ¿AROUND 25¿ MG/DL WAS REPORTED USING AN UNKNOWN DEVICE AT THE TIME OF HEALTHCARE PROFESSIONAL (HCP) CONTACT WHO PERFORMED A LAB BLOOD TEST, HOWEVER THE LAB RESULT WERE NOT REPORTED. THE CUSTOMER WAS ADMINISTERED GLUCOSE BY THE HCP FOR THE DIAGNOSIS OF HYPOGLYCEMIA. A LABORATORY RESULT WAS REPORTEDLY OBTAINED BUT THE RESULTS WERE UNSPECIFIED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230039 FREESTYLE LIBRE 3 PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 78768-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention