BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1020842 · Received May 30, 2007

    Report

    Report Number
    2954323-2007-09038
    Event Type
    Malfunction
    Date Received
    May 30, 2007
    Date of Event
    April 30, 2007
    Report Date
    May 30, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S METER HAS BEEN RETURNED AND AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A COMPLAINT OF IMPRECISE SEQUENTIAL READINGS ON HIS FREESTYLE FLASH BLOOD GLUCOSE METER. THE CUSTOMER OBTAINED READINGS OF 48 MG/DL AND A "HI" MESSAGE WITHIN A TEN MINUTE TIMEFRAME. A "HI" MESSAGE INDICATES A BLOOD GLUCOSE READING GREATER THAN 500MG/DL. ALL READINGS WERE TAKEN FROM THE FINGER. WHEN PLOTTED ON A PARKES ERROR GRID THE RESULTS FALL IN THE 'D' ZONE, WHICH SHOWS THE DIFFERENCE TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. NI 0633813

    Patients

    Seq Age Sex Outcome Treatment
    1 NI