BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 2

    MDR report key: 11896586 · Received May 27, 2021

    Report

    Report Number
    2954323-2021-70525
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    May 8, 2021
    Report Date
    May 27, 2021
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    UDI-DI
    00357599800000
    PMA / PMN Number
    K193371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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. DHRS (DEVICE HISTORY RECORD) FOR THE LIBRE SENSOR AND LIBRE SENSOR KITS WERE REVIEWED AND THE DHRS SHOWED THE LIBRE SENSOR AND LIBRE SENSOR KITS PASSED ALL TESTS PRIOR TO RELEASE. 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 · 1

    A CUSTOMER REPORTED OBTAINING A "NEW SENSOR STARTING" MESSAGE FROM THE ADC FREESTYLE LIBRE 2 SENSOR. THE CUSTOMER WAS UNABLE TO OBTAIN READINGS AND BECAME CLAMMY, SUBSEQUENTLY LOSING CONSCIOUSNESS. AN AMBULANCE WAS CALLED AND UPON ARRIVAL, AN HCP METER READING OF 22 MG/DL WAS OBTAINED AND CUSTOMER RECEIVED GLUCAGON INJECTION, FOOD, AND DRINK AS TREATMENT FOR DIAGNOSIS OF HYPOGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788276 FREESTYLE LIBRE 2 FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71992-01 00357599800000

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention