BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1010457 · Received May 11, 2007

    Report

    Report Number
    2954323-2007-07701
    Event Type
    Malfunction
    Date Received
    May 11, 2007
    Date of Event
    April 12, 2007
    Report Date
    May 11, 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

    THIS AN INITIAL REPORT. LAN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE ADC FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ERROR 4, WHEN TEST STRIP WAS INSERTED AND A BATTERY AND BOOKLET ICON APPEARED ON THE DISPLAY OF THEIR FREESTYLE FLASH BLOOD GLUCOSE MONITOR. ALTHOUGH IT IS UNKNOWN IF THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE METER IS EXHIBITING SIGNS OF THE MEMORY OVERWRITE MALFUNCTION. THE CUSTOMER REPORTED FEELING WEAK AND DIZZY, BEING DIAGNOSED WITH HYPOGLYCEMIA, AND HAVING TO EAT CANDY, CAKE, AND DRINK JUICE TO STABILIZE GLUCOSE LEVELS. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY 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 0426509

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK