BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 16165096 · Received January 13, 2023

    Report

    Report Number
    2954323-2023-02379
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    December 21, 2022
    Report Date
    January 14, 2023
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QLG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, PRODUCT HAS NOT YET BEEN RETURNED AND A VALID SERIAL HAS NOT BEEN PROVIDED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND DETERMINED THAT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. A TRIPPED TREND REVIEW WAS CONDUCTED FOR THE REPORTED COMPLAINT AND FS LIBRE READER NO TRENDS WERE IDENTIFIED THAT WOULD INDICATE ANY PRODUCT RELATED ISSUES. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, MODEL NUMBER 72111-01 WHICH HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., MODEL NUMBER 71953-01. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    AN ERROR MESSAGE WAS REPORTED WITH THE ADC DEVICE. CUSTOMER RECEIVED A "CONNECTED TO COMPUTER" MESSAGE AND WAS UNABLE TO OBTAIN READINGS. AS A RESULT, CUSTOMER EXPERIENCED HYPERGLYCEMIA AND WAS UNABLE TO SELF-TREAT, REQUIRING THIRD-PARTY ADMINISTRATION OF INSULIN SYRINGE (INJECTION) FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186795 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE LTD 71953-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention