BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 17355998 · Received July 19, 2023

    Report

    Report Number
    2954323-2023-31254
    Event Type
    Injury
    Date Received
    July 19, 2023
    Date of Event
    July 13, 2023
    Report Date
    July 19, 2023
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QBG
    PMA / PMN Number
    K223435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE DEVICE HISTORY RECORDS (DHRS) FOR THE FREESTYLE LIBRE SENSOR KIT WERE REVIEWED AND THE DHRS SHOWED THE FREESTYLE LIBRE SENSOR KIT PASSED ALL TESTS PRIOR TO RELEASE. THE DATE OF EVENT IS UNKNOWN. THE DATE ENTERED IN SECTION B3 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. 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 · 0

    AN ADHESIVE ISSUE WAS REPORTED WITH THE ADC SENSOR. THE SENSOR PREMATURELY DETACHED AND THE CUSTOMER WAS UNABLE TO OBTAIN READINGS. AS A RESULT, CUSTOMER REQUIRED THIRD-PARTY MEDICAL TREATMENT. NO FURTHER DETAILS WERE PROVIDED AND ATTEMPTS TO GATHER ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34890 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QBG ABBOTT DIABETES CARE LTD 72081-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention