BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1771060 · Received June 19, 2007

    Report

    Report Number
    2954323-2007-10756
    Event Type
    Malfunction
    Date Received
    June 19, 2007
    Date of Event
    April 13, 2007
    Report Date
    June 19, 2007
    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

    (B)(4). THE METER HAS BEEN CONFIRMED TO EXHIBIT THE MEMORY OVERWRITE MALFUNCTION. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE ADC FA16MAY2006 LETTER.

    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 NOT BEING ABLE TO PROPERLY ADMINISTER THEIR DIABETES RELATED MEDICATIONS AS A RESULT OF 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 0701623

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK