BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1020899 · Received May 30, 2007

    Report

    Report Number
    2954323-2007-09145
    Event Type
    Malfunction
    Date Received
    May 30, 2007
    Date of Event
    May 2, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER HAS BEEN CONFIRMED TO EXHIBIT THE MEMORY OVERWRITE MALFUNCTION. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN ISSUE WITH THEIR FREESTYLE FLASH METER. UPON PRODUCT INVESTIGATION IT WAS DISCOVERED THE METER EXHIBITED THE MEMORY OVERWRITE MALFUNCTION. THE CUSTOMER REPORTED DELAYING HER BREAKFAST DUE TO METER MALFUNCTION, AND HAD ONE EPISODE OF FALLING ON THE FLOOR. 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. NA 0614334

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK