BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 2

    MDR report key: 16293704 · Received February 3, 2023

    Report

    Report Number
    2954323-2022-39868
    Event Type
    Injury
    Date Received
    February 3, 2023
    Date of Event
    September 30, 2022
    Report Date
    February 3, 2023
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    PMA / PMN Number
    K193371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. A TRIPPED TREND REVIEW WAS CONDUCTED FOR THE REPORTED COMPLAINT, AND THE FREESTYLE LIBRE 2 READER, AND NO TRENDS WERE IDENTIFIED THAT WOULD INDICATE ANY PRODUCT RELATED ISSUES. THE DHR (DEVICE HISTORY RECORD) FOR THE PRECISION TEST STRIPS WAS REVIEWED, AND THE DHR SHOWED THE PRECISION TEST STRIPS PASSED ALL TESTS PRIOR TO RELEASE. RETAIN TESTING WAS PERFORMED FOR THE PRECISION TEST STRIPS, AND ALL UNITS PERFORMED IN SPECIFICATION AND PASSED. 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

    A CUSTOMER REPORTED AN ERROR MESSAGE WITH THE ADC DEVICE, UPON TEST STRIP INSERTION. THE CUSTOMER WAS THEREFORE UNABLE TO OBTAIN GLUCOSE RESULTS AND BECAME HYPOGLYCEMIC WITH DIZZINESS, BLURRED VISION, FATIGUE, AND TACHYCARDIA. THE CUSTOMER WAS TREATED WITH GLUCAGON INJECTION BY RELATIVE. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823110 FREESTYLE LIBRE 2 FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71953-01 4500185922

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention