BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 805493 · Received January 4, 2007

    Report

    Report Number
    2954323-2007-00027
    Event Type
    Malfunction
    Date Received
    January 4, 2007
    Date of Event
    September 8, 2006
    Report Date
    January 4, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT IS CONFIRMED. PERFORMED INVESTIGATION USING RETURNED METER. METER IS UNLOCKED TO MG/DL. THE 0300, 0015, 0204, 0800, 0806 ERRORS WERE FOUND IN ERROR LOG. E3/E4 ERRORS WITH LOW BATTERY ICON WERE NOT OBSERVED. CALIBRATION PARAMETERS WERE WITHIN SPECIFICATION. MEMORY OVERWRITE WAS OBSERVED. METER IS OPERABLE. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED 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. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR