BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 2 SENSOR

    MDR report key: 16809910 · Received April 24, 2023

    Report

    Report Number
    MW5117022
    Event Type
    Injury
    Date Received
    April 24, 2023
    Date of Event
    April 15, 2023
    Report Date
    April 20, 2023
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    MDS
    UDI-DI
    00357599800000
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT WITH DIABETES WAS USING FREESTYLE LIBRE 2 MANUFACTURED BY ABBOTT DIABETES CARE INC. TO MONITOR BLOOD GLUCOSE LEVEL. FREESTYLE SENSOR GAVE OFF FALSE LOW GLUCOSE READINGS INDICATED THROUGH ITS ALARM SYSTEM THAT THE PATIENT NEEDED TO ADDRESS THE HYPOGLYCEMIA CONDITION. THE PROTOCOL IS TO TAKE ACTION QUICKLY BY TAKING QUICK FIX FOODS. DURING THE LAST SIX WEEKS PATIENT HAS EXPERIENCED 50 % FAILURE OF THE LIBRE 2 SENSORS. OTHER PROBLEMS WITH THIS PRODUCT INCLUDE: CONTACTING ABBOTT TO REPORT FAILURES. ABBOTT USES INTERNATIONAL CALL CENTERS WITH STAFF THAT USES POOR ENGLISH AND ARE DIFFICULT TO UNDERSTAND. POOR TELEPHONE CONNECTION WITH BACKGROUND NOISE. LIBRE 2 SENSORS LAST FOR TWO WEEKS OR 14 DAYS. SOME OF THE SENSORS STOP WORKING PRIOR TO THE FOURTEEN-DAY TERM. ABBOTT CUSTOMER SERVICE SUGGESTED RETURNING UNUSED SENSORS THAT HAVE THE SAME "LOT NUMBER" AS THE DEFECTIVE UNIT. THE PHARMACY REFUSED THIS OPTION. FAILURE OF THIS PRODUCT CAN CAUSE SERIOUS AFTEREFFECTS. ABBOTT NEEDS TO RECALL THIS PRODUCT WHEN PROBLEMS ARISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746549 FREESTYLE LIBRE 2 SENSOR SENSOR, GLUCOSE, INVASIVE MDS ABBOTT DIABETES CARE INC. LIBRE 2 KTP005524 00357599800000

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Life Threatening