BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1008846 · Received May 3, 2007

    Report

    Report Number
    2954323-2007-06560
    Event Type
    Malfunction
    Date Received
    May 3, 2007
    Date of Event
    April 3, 2007
    Report Date
    May 3, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. FOLLOW UP REPORT WILL BE SUBMITTED IF THE PRODUCT IS RETURNED FOR EVALUATION. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE ADC FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ERROR MESSAGE AND ADD'L ICONS ON HER UNLOCKED FREESTYLE FLASH METER. THESE MESSAGES ARE AN INDICATION THE DEVICE MAY HAVE EXHIBITED THE MEMORY OVERWRITE MALFUNCTION. CUSTOMER ALSO NOTED THE UNIT OF MEASURE HAD CHANGED FROM MMOL/L TO MG/DL. 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 0509755

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO