BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRELINK

    MDR report key: 10214571 · Received June 30, 2020

    Report

    Report Number
    2954323-2020-04438
    Event Type
    Injury
    Date Received
    June 30, 2020
    Date of Event
    June 22, 2020
    Report Date
    August 11, 2020
    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

    ADC PRODUCT QUALITY ENGINEERING (PQE) INVESTIGATED THIS COMPLAINT IN WHICH THE USER REPORTED NOT BEING ABLE TO SCAN A LIBRE SENSOR WHEN USING A SAMSUNG S9 DEVICE WITH ANDROID 10 WHEN THE BATTERY WAS BELOW 80%. PQE ATTEMPTED TO REPLICATE THE COMPLAINT USING A SIMILAR CONFIGURATION AND WAS NOT ABLE TO REPLICATE THE ISSUE. RESEARCH & DEVELOPMENT ALSO TRIED TO REPLICATE THIS ISSUE USING A SAMSUNG 9 WITH DIFFERENT OS VERSIONS (8, 9, 10), A LIBRE SENSOR, AND DIFFERENT BATTERY LEVELS. THE SENSOR SCANNED SUCCESSFULLY WITHOUT ANY ISSUES UNDER ALL SCENARIOS. AS PQE WAS NOT ABLE TO REPLICATE THE USER COMPLAINT, THE COMPLAINT IS NOT CONFIRMED. NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED BEING UNABLE TO SCAN THE ADC FREESTYLE LIBRE SENSOR USING THE ANDROID LIBRE LINK APP 10 WHEN THE SENSOR BATTERY IF BELOW 80%. CUSTOMER FURTHER REPORTED BEING UNWELL AND EXPERIENCED HEADACHE AND WAS TREATED WITH SUGAR BY A NON-HCP. NO FURTHER TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DEVICE MFG DATE IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BEING UNABLE TO SCAN THE ADC FREESTYLE LIBRE SENSOR USING THE ANDROID LIBRE LINK APP 10 WHEN THE SENSOR BATTERY IF BELOW 80%. CUSTOMER FURTHER REPORTED BEING UNWELL AND EXPERIENCED HEADACHE AND WAS TREATED WITH SUGAR BY A NON-HCP. NO FURTHER TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675746 FREESTYLE LIBRELINK DATA MANAGEMENT SYSTEM PZE ABBOTT DIABETES CARE INC 71733-01

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention