BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 1010184 · Received March 10, 2008

    Report

    Report Number
    2954323-2008-01022
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 8, 2008
    Report Date
    March 7, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A LOW READING OF 100 MG/DL ON HER FREESTYLE BLOOD GLUCOSE MONITOR. A REFERENCE VALUE OF 249 MG/DL WAS RECEIVED ON A LAB'S METER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FALL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC., USA NI 0435806

    Patients

    Seq Age Sex Outcome Treatment
    1 NA