BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRELINK

    MDR report key: 23083131 · Received September 18, 2025

    Report

    Report Number
    2954323-2025-37451
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    September 9, 2025
    Report Date
    September 22, 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

    INVESTIGATION IS PENDING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. 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 PRODUCT INFORMATION PROVIDED IS FOR IOS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    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. 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. 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. 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 CUSTOMER REPORTED FOR MISSING HIGH AND LOW ALARMS. THE REPORTED ISSUE WAS INVESTIGATED. ATTEMPT TO IDENTIFY THE CUSTOMER'S REPORTED CONFIGURATIONS AND THE INFORMATION PROVIDED IN THE COMPLAINT WAS INSUFFICIENT TO CONDUCT A COMPREHENSIVE INVESTIGATION. THE LACK OF INFORMATION REGARDING THE DEVICE MODEL AND PROPER OS VERSION, RESTRICTS THE ABILITY TO IDENTIFY POTENTIAL CAUSES OF THE CUSTOMER'S REPORTED ISSUE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT UNKNOWN PHONE, OPERATING SYSTEM AND VERSION. THE HIGH AND LOW GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER EXPERIENCED CONVULSION WITH LOSS OF CONSCIOUSNESS, "LEG LOCKAGE", AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER WAS TREATED WITH ORANGE COMPOTE AND THEIR SENSOR WAS REMOVED BY A NON-HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT UNKNOWN PHONE, OPERATING SYSTEM VERSION AND APP VERSION. THE HIGH AND LOW GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER EXPERIENCED CONVULSION WITH LOSS OF CONSCIOUSNESS, "LEG LOCKAGE", AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER WAS TREATED WITH ORANGE COMPOTE AND THEIR SENSOR WAS REMOVED BY A NON-HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1648733 FREESTYLE LIBRELINK DATA MANAGEMENT SYSTEM PZE ABBOTT DIABETES CARE INC 71733-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention