BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 1010181 · Received March 10, 2008

    Report

    Report Number
    2954323-2007-26592
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    November 28, 2007
    Report Date
    December 21, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S METER HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE DONE ONCE THE INVESTIGATION IS COMPLETE. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING AN ERR4 MESSAGE ON TEST STRIP INSERTION AND A BATTERY AND BOOKLET ICON WERE PRESENT ON THEIR FREESTYLE FLASH METER. THE METER IS EXHIBITING SIGNS OF THE MEMORY OVERWRITE MALFUNCTION. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC., USA NI 0717316

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK