BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1191577 · Received October 1, 2008

    Report

    Report Number
    2954323-2008-02645
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 5, 2008
    Report Date
    October 1, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE METER HAS BEEN RETURNED AND AN INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE FILED ONCE THE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING INACCURATE BLOOD GLUCOSE TESTS ON THEIR FREESTYLE METER. CUSTOMER RECEIVED READINGS OF 141 MG/DL COMPARED TO A LAB READING OF 81 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 NA 0801838

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK