BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1020841 · Received May 30, 2007

    Report

    Report Number
    2954323-2007-09074
    Event Type
    Malfunction
    Date Received
    May 30, 2007
    Date of Event
    May 1, 2007
    Report Date
    May 30, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THEY OBSERVED AN ERROR 4 MESSAGE DISPLAYED ON THEIR FREESTYLE FLASH METER DURING THE INSERTION OF A TEST STRIP. THE CUSTOMER ALSO OBSERVED THE LOW BATTERY AND BOOKLET ICONS. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI