BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 812453 · Received January 17, 2007

    Report

    Report Number
    2954323-2007-00242
    Event Type
    Malfunction
    Date Received
    January 17, 2007
    Date of Event
    December 19, 2006
    Report Date
    January 17, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONFIRMED. TESTED RETURNED UNIT. NO MANUFACTURING PARAMETERS FOUND OUT OF SPEC. HOWEVER, UOM WAS SELECTABLE AND WAS RECEIVED AT MMOL/LS. ERRORS 015, 0204, 0300, 0800 AND 0806 WERE OBSERVED IN THE ERROR LOG INDICATING BATTERY DROOP. METER IS OPERABLE. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTE D THAT THE UOM SETTING OF THEIR FREESTYLE METER CHANGED FROM MMOL/L TO MG/DL. 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 YR