BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 2973794 · Received July 20, 2007

    Report

    Report Number
    2954323-2007-13099
    Event Type
    Malfunction
    Date Received
    July 20, 2007
    Date of Event
    June 7, 2007
    Report Date
    July 20, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE METER HAS BEEN CONFIRMED TO EXHIBIT THE MEMORY OVERWRITE MALFUNCTION. CUSTOMER AND RETAILERS HAVE BEEN INFORMED THROUGH THE FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ISSUE WITH THEIR METER. UPON INVESTIGATION, THE METER WAS FOUND TO EXHIBIT THE MEMORY OVERWRITE MALFUNCTION. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM (NBW) NBW ABBOTT DIABETES CARE INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK