BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRELINK

    MDR report key: 22472732 · Received July 10, 2025

    Report

    Report Number
    2954323-2025-26508
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    June 28, 2025
    Report Date
    July 10, 2025
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED MISSING HIGH AND LOW ALARMS. ABBOTT DIABETES CARE (ADC) ATTEMPTED TO REPLICATE THE REPORTED ISSUE AND THE REPORTED CONFIGURATION; HOWEVER, THE INFORMATION PROVIDED IN THE COMPLAINT WAS INSUFFICIENT TO CONDUCT A COMPREHENSIVE INVESTIGATION. THE LACK OF THE APP VERSION, OS, AND DEVICE MAKE/MODEL 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 DATE OF EVENT IS UNKNOWN. THE DATE ENTERED IN SECTION B3 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. THE DEVICE MANUFACTURING DATE DOES NOT APPLY. THE DATE ENTERED IN SECTION H4 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. THE OPERATING SYSTEM IS UNKNOWN SO THE G4 - PMA/510(K) NUMBER POPULATED IS FOR IOS. SECTION D. SUSPECTED MEDICAL DEVICE AND G4 - PMA/510(K)# HAS BEEN POPULATED FOR THE FREESTYLE LIBRELINK IOS APPLICATION AS THIS REPORT CONCERNS A LEBANON CUSTOMER. THIS IS SAME/SIMILAR TO US FREESTYLE LIBRE 2 IOS APPLICATION, MODEL NUMBER 71926-01. 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 DIABETES CARE (ADC) DEVICE IN USE WITH AN UNKNOWN PHONE WITH AN UNKNOWN OPERATING SYSTEM VERSION. THE LOW AND HIGH GLUCOSE ALARMS DID NOT SOUND, AND THE CUSTOMER WAS NOT ALERTED TO CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS AND RECEIVED UNSPECIFIED THIRD-PARTY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120457 FREESTYLE LIBRELINK DATA MANAGEMENT SYSTEM PZE ABBOTT DIABETES CARE INC 71733-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention