BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 1020155 · Received May 25, 2007

    Report

    Report Number
    2954323-2007-08870
    Event Type
    Malfunction
    Date Received
    May 25, 2007
    Date of Event
    January 30, 2007
    Report Date
    May 25, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    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, THAT THEY OBSERVED AN ERROR 3 MESSAGE ON THE SCREEN OF THEIR FREESTYLE BLOOD GLUCOSE MONITOR. THE CUSTOMER ALSO OBSERVED THE LOW BATTERY AND BOOKLET ICONS. THE CUSTOMER'S METER WAS RETURNED FOR INVESTIGATION AND TESTING CONFIRMED THE METER TO EXHIBIT 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI