BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1060763 · Received June 12, 2008

    Report

    Report Number
    2954323-2008-02093
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 15, 2008
    Report Date
    June 12, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING INACCURATE BLOOD GLUCOSE RESULTS. CUSTOMER RECEIVED A READING OF 136 MG/DL COMPARED TO A LAB READING OF 77 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL 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 FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI