BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1801296 · Received September 21, 2007

    Report

    Report Number
    2954323-2007-17796
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    August 24, 2007
    Report Date
    September 21, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S PRODUCT HAS BEEN RETURNED. A FOLLOW-UP REPORT WILL BE COMPLETED ONCE THE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR FREESTYLE FREEDOM BLOOD GLUCOSE MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF 75 MG/DL, 97 MG/DL, 118 MG/DL, 126 MG/DL, 105 MG/DL, "HI" ( A "HI" MESSAGE INDICATES A READING GREATER THAN 500 MG/DL) AND 268 MG/DL WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. 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 FREEDOM BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC, USA NI 0709516

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK