BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRELINK

    MDR report key: 22596059 · Received July 24, 2025

    Report

    Report Number
    2954323-2025-28872
    Event Type
    Injury
    Date Received
    July 24, 2025
    Date of Event
    July 14, 2025
    Report Date
    July 24, 2025
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED ERROR COMMUNICATING WITH THE SERVER WAS INVESTIGATED. AFTER ATTEMPTING TO IDENTIFY THE CUSTOMER'S REPORTED CONFIGURATIONS, THE INFORMATION PROVIDED IN THE COMPLAINT WAS INSUFFICIENT TO CONDUCT A COMPREHENSIVE INVESTIGATION. THE LACK OF THE DEVICE MAKE/MODEL, APP VERSION AND OS RESTRICTS THE ABILITY TO IDENTIFY POTENTIAL CAUSES OF THE CUSTOMER'S REPORTED ISSUE. THEREFORE, THE REPORTED ISSUE IS NOT CONFIRMED DUE TO THE INADEQUATE INFORMATION PROVIDED. THE MOST PROBABLE ROOT CAUSES ASSOCIATED WITH THIS FAILURE MODE ARE SOFTWARE/DATA CORRUPTION OR MISUSE. HOWEVER, MITIGATIONS ARE IN PLACE TO REDUCE AND PREVENT SUCH ISSUES. 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. SECTION D. SUSPECTED MEDICAL DEVICE AND G4 - PMA/510(K)# HAS BEEN POPULATED FOR THE FREESTYLE LIBRELINK IOS APPLICATION AS THIS REPORT CONCERNS A FRANCE CUSTOMER. THIS IS SAME/SIMILAR TO US FREESTYLE LIBRE 2 IOS APPLICATION, MODEL NUMBER 71926-01. THE OPERATING SYSTEM IS UNKNOWN SO THE D4 - MODEL # AND D4 - PRIMARY UDI NUMBER POPULATED ARE FOR IOS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    AN APPLICATION RELATED ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH AN UNKNOWN PHONE WITH AN UNKNOWN OPERATING SYSTEM VERSION. THE CUSTOMER WAS UNABLE TO ACCESS THEIR FREESTYLE LIBRELINK ACCOUNT DUE TO AN ERROR IN COMMUNICATION WITH THE NETWORK SERVER, WHICH PREVENTED THE CUSTOMER FROM MONITORING THEIR GLUCOSE LEVELS. SUBSEQUENTLY, THE CUSTOMER EXPERIENCED SYMPTOMS INCLUDING A SENSATION OF COLD IN THE BACK, BLURRED VISION, NUMBNESS IN THE LEGS, SWEATING, JOINT PAIN, AND CONFUSION. IN RESPONSE, A NON-HEALTHCARE PROFESSIONAL (HCP) PROVIDED THE CUSTOMER WITH A CAN OF SODA. EMERGENCY SERVICES WERE CONTACTED, AND UPON ARRIVAL, AN HCP RECORDED A BLOOD GLUCOSE READING OF "57 MG/DL". THE CUSTOMER WAS THEN TAKEN TO THE HOSPITAL WHERE FURTHER TREATMENT OF BREAD AND JAM WAS PROVIDED FOR THE DIAGNOSIS OF HYPOGLYCEMIA. THE CUSTOMER WAS HOSPITALIZED OVERNIGHT AND LEFT THE FOLLOWING DAY. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2126513 FREESTYLE LIBRELINK DATA MANAGEMENT SYSTEM PZE ABBOTT DIABETES CARE INC 71733-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H