BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 15903219 · Received December 2, 2022

    Report

    Report Number
    2954323-2022-44112
    Event Type
    Injury
    Date Received
    December 2, 2022
    Date of Event
    November 4, 2022
    Report Date
    December 2, 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. 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. THE DEVICE MANUFACTURING DATE IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A SIGNAL LOSS ALARM ISSUE WAS REPORTED WITH THE ADC DEVICE. A CUSTOMER REPORTED THAT THE LOSS OF SIGNAL RESULTED IN THE HYPOGLYCEMIA. THE CUSTOMER EXPERIENCED SYMPTOMS OF DIZZINESS AND HAD NO STRENGTH. THE CUSTOMER HAD CONTACT WITH DOCTOR AND A READING OF 49 MG/DL WAS OBTAINED ON THE HCP METER AND WAS TREATED WITH AN UNSPECIFIED INJECTION. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1797460 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE LTD 71953-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention