BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 15848909 · Received November 22, 2022

    Report

    Report Number
    2954323-2022-42841
    Event Type
    Injury
    Date Received
    November 22, 2022
    Date of Event
    October 21, 2022
    Report Date
    November 23, 2022
    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 NUMBER HAS NOT BEEN PROVIDED. 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. 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. 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. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A SETTINGS/MEMORY ISSUE WAS REPORTED WITH THE ADC DEVICE. THE CUSTOMER REPORTED DEVICE DISPLAYS WRONG VALUES EVERY TIME A GLUCOSE TEST WAS PERFORMED. AS A RESULT, CUSTOMER EXPERIENCED SYMPTOMS OF HYPERGLYCEMIA, BLURRED VISION, MALAISE AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL WHO PROVIDED UNSPECIFIED DOSE INSULIN INJECTION AS TREATMENT. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309673 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE LTD 71953-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention