BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1052667 · Received May 29, 2008

    Report

    Report Number
    2954323-2007-08764
    Event Type
    Malfunction
    Date Received
    May 29, 2008
    Date of Event
    April 28, 2007
    Report Date
    May 24, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED AN ISSUE WITH THIER METER WHICH SUGGEST THE MEMORY OVERWRITE MALFUNCTION HAS OCCURRED. THE PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE METER IS RETURNED. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ISSUE WITH THEIR METER WHICH SUGGESTS THE MEMORY OVERWRITE MALFUNCTION HAS OCCURRED. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC NI 0529345

    Patients

    Seq Age Sex Outcome Treatment
    1