BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 20106095 · Received August 30, 2024

    Report

    Report Number
    2954323-2024-33478
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    August 21, 2024
    Report Date
    August 30, 2024
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QBJ
    PMA / PMN Number
    K223435
    Removal / Correction Number
    QUALITY RECORD QR987974
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADC INVESTIGATED THIS ISSUE AND DETERMINED THAT THE FREESTYLE LIBRE 3 SENSOR ASSOCIATED WITH THIS COMPLAINT DID NOT MEET PRODUCT DESIGN SPECIFICATIONS AND MAY PRODUCE HIGH GLUCOSE READINGS WHICH ARE NOT CLINICALLY ACCEPTABLE. BASED ON THE RESULTS OF THIS INVESTIGATION, THIS COMPLAINT IS CONFIRMED. THIS ISSUE WAS ADDRESSED BY THE FIELD ACTION 1034-2024 (FDA RECALL 2954323-07/24/24-001-R). IF THE PRODUCT IS RETURNED, NO FURTHER INVESTIGATION ACTIONS ARE REQUIRED AS THIS ISSUE IS CONFIRMED TO ADC FA1034-2024. ALL PERTINENT INFORMATION AVAILABLE TO ADC HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED RECEIVING HIGH GLUCOSE SENSOR READINGS FROM AN ABBOTT DIABETES CARE (ADC) DEVICE. THIS IS A KNOWN ISSUE FOR THE SERIAL NUMBER ASSOCIATED WITH THIS COMPLAINT, ADDRESSED BY THE FIELD ACTION 1034-2024 (FDA RECALL2954323-07/24/24-001-R). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1802683 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QBJ ABBOTT DIABETES CARE LTD 72081-01

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female