BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRELINK

    MDR report key: 19094970 · Received April 12, 2024

    Report

    Report Number
    2954323-2024-12375
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    April 3, 2024
    Report Date
    April 12, 2024
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    UDI-DI
    00357599000059
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND IT HAS BEEN DETERMINED THAT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE CUSTOMER EXPERIENCED "MISSING HIGH AND LOW ALARMS" WITH THE FREESTYLE LIBRELINK APPLICATION. PRODUCT QUALITY ENGINEERING ATTEMPTED TO REPLICATE THE REPORTED ISSUE USING A CELLULAR DEVICE NOT IDENTICAL TO THE ACTUAL DEVICE, BUT WHICH SHARES RELEVANT CHARACTERISTICS WITH THE DEVICE INVOLVED AND IOS OPERATING SYSTEM VERSION 17.1.2 AND APP VERSION 2.10.2.7677, AND WAS NOT ABLE TO REPRODUCE THE COMPLAINT. THERE WERE NO ISSUES IDENTIFIED WITH THE FREESTYLE LIBRELINK APP DURING REPLICATION THAT WOULD HAVE LED TO THE REPORTED ISSUE. THE DEVICE MANUFACTURING DATE DOES NOT APPLY. THE DATE ENTERED IN SECTION H4 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. SECTION D. SUSPECTED MEDICAL DEVICE AND G4 - PMA/510(K)# HAS BEEN POPULATED FOR THE FREESTYLE LIBRELINK IOS APPLICATION AS THIS REPORT CONCERNS A [COMPLAINT COUNTRY] CUSTOMER. THIS IS SAME/SIMILAR TO US FREESTYLE LIBRE 2 IOS/ANDROID APPLICATION PART 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 ADC APPLICATION IN USE A IPHONE 12 PHONE WITH IOS VERSION 17.3.1 OPERATING SYSTEM. THE LOW AND HIGH GLUCOSE ALARMS DID NOT SOUND AND CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS, "LOSS OF KNOWLEDGE", AND WAS UNABLE TO SELF-TREAT, REQUIRING THIRD-PARTY TREATMENT OF "COCA-COLA" BY A NON-HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508791 FREESTYLE LIBRELINK DATA MANAGEMENT SYSTEM PZE ABBOTT DIABETES CARE INC 71733-01 00357599000059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention