BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1020150 · Received May 25, 2007

    Report

    Report Number
    2954323-2007-08865
    Event Type
    Malfunction
    Date Received
    May 25, 2007
    Date of Event
    April 26, 2007
    Report Date
    May 25, 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

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION. A F/U REPORT WILL BE SUBMITTED IF THE METER IS RECEIVED. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE ADC FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED, THAT THE UNITS OF MEASUREMENT OF THEIR FREESTYLE BLOOD GLUCOSE MONITOR CHANGED. THE CUSTOMER ALSO OBSERVED AN ERROR 4 MESSAGE DURING THE INSERTION OF A TEST STRIP. THE METER IS ONE, WHERE THE CUSTOMER CANNOT INADVERTENTLY CHANGE THE UNITS OF MEASUREMENT. 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 FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI