BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 16228854 · Received January 23, 2023

    Report

    Report Number
    2954323-2023-03712
    Event Type
    Injury
    Date Received
    January 23, 2023
    Date of Event
    January 3, 2023
    Report Date
    February 24, 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

    READER (B)(6) HAS BEEN RETURNED AND INVESTIGATED. VISUAL INSPECTION HAS BEEN PERFORMED AND NO ISSUES WERE OBSERVED. PERFORMED BUILT-IN READER TEST AND THE READER TEST PASSED. NO ERRORS WERE OBSERVED. THEREFORE, THIS ISSUE IS NOT CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    AT THIS TIME, PRODUCT HAS NOT YET BEEN RETURNED. 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 DHR (DEVICE HISTORY REVIEW) FOR THE FS LIBRE READER WAS REVIEWED AND THE DHR SHOWED THE FS LIBRE READER PASSED ALL TESTS PRIOR TO RELEASE. 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

    A CUSTOMER REPORTED AN "ERROR-9" MESSAGE WITH THE ADC DEVICE. THE CUSTOMER REPORTED EXPERIENCING SEIZURE AND REQUIRED UNSPECIFIED TREATMENT FROM A HEALTHCARE PROFESSIONAL. NO FURTHER INFORMATION WAS PROVIDED AS CUSTOMER DECLINED TO PROVIDE DETAILS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED AN "ERROR-9" MESSAGE WITH THE ADC DEVICE. THE CUSTOMER REPORTED EXPERIENCING SEIZURE AND REQUIRED UNSPECIFIED TREATMENT FROM A HEALTHCARE PROFESSIONAL. NO FURTHER INFORMATION WAS PROVIDED AS CUSTOMER DECLINED TO PROVIDE DETAILS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568029 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE LTD 71953-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention