BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRELINK

    MDR report key: 25118288 · Received May 7, 2026

    Report

    Report Number
    2954323-2026-67722
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 7, 2026
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. 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. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. SECTION D. SUSPECTED MEDICAL DEVICE AND G4 - PMA/510(K)# HAS BEEN POPULATED FOR THE FREESTYLE LIBRELINK IOS APPLICATION AS THIS REPORT CONCERNS A SWEDEN CUSTOMER. THIS IS SAME/SIMILAR TO US FREESTYLE LIBRE 2 IOS APPLICATION, MODEL NUMBER 71926-01.

    Description of Event or Problem · 0

    AN LOW ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH UNKNOWN PHONE TYPE WITH UNKNOWN OPERATING SYSTEM. THE CUSTOMER WAS UNABLE TO RECEIVE GLUCOSE ALARMS. AS A RESULT, THE CUSTOMER EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA AND LOST CONSCIOUSNESS. THE CUSTOMER WAS UNABLE TO SELF-TREAT, REQUIRING UNSPECIFIED THIRD-PARTY TREATMENT FROM A HEALTHCARE PROFESSIONAL (HCP). DETAILS OF THE TYPE OF TREATMENT 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
    480456 FREESTYLE LIBRELINK DATA MANAGEMENT SYSTEM PZE ABBOTT DIABETES CARE INC 71733-01

    Patients

    Seq Age Sex Outcome Treatment
    1