BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 822223 · Received January 25, 2007

    Report

    Report Number
    2954323-2007-00391
    Event Type
    Malfunction
    Date Received
    January 25, 2007
    Date of Event
    October 14, 2006
    Report Date
    January 25, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT IS CONFIRMED. PERFORMED INVESTIGATION. MEMORY OVERWRITE WAS OBSERVED. FOUND OUM TO BE SELECTABLE AND SET TO MG/DL. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ERROR MESSAGE ON HER LOCKED FREESTYLE METER. THE DEVICE WAS RETURNED AND DURING THE COURSE OF THE INVESTIGATION, IT WAS DISCOVERED THE METER HAD SUFFERED THE MEMORY OVERWRITE MALFUNCTION. 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 BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NI 0607353

    Patients

    Seq Age Sex Outcome Treatment
    1 YR