BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 14247552 · Received April 29, 2022

    Report

    Report Number
    2954323-2022-13888
    Event Type
    Injury
    Date Received
    April 29, 2022
    Date of Event
    April 6, 2022
    Report Date
    April 28, 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. 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. THE DHRS (DEVICE HISTORY RECORD) FOR THE LIBRE SENSOR KIT WERE REVIEWED, AND THE DHRS SHOWED THE LIBRE SENSOR KIT PASSED ALL TESTS PRIOR TO RELEASE. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. THE DEVICE MANUFACTURING DATE IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, MODEL NUMBER 72114-01, WHICH HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., MODEL NUMBER 71992-01. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THE ADC DEVICE DETACHED PREMATURELY AFTER 3 DAYS OF WEAR. THE CUSTOMER THEREFORE DID NOT HAVE SENSOR TO MONITOR GLUCOSE AND BECAME DIZZY WITH OTHER UNSPECIFIED HYPOGLYCEMIA SYMPTOMS. AN AMBULANCE WAS CALLED AND CUSTOMER RECEIVED TREATMENT, WHICH COULD NOT BE RECALLED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119834 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE LTD 72114-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention