BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1905461 · Received December 5, 2007

    Report

    Report Number
    2954323-2007-24504
    Event Type
    Malfunction
    Date Received
    December 5, 2007
    Date of Event
    November 6, 2007
    Report Date
    December 5, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S PRODUCT HAS BEEN RETURNED AND AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR FREESTYLE METER. CUSTOMER REPORTED RECEIVING READINGS OF 20 MG/DL, 67 MG/DL, 2 MG/DL, 102 MG/DL, 116 MG/DL AND 89 MG/DL WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE ARM. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONES 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 NA 0723938

    Patients

    Seq Age Sex Outcome Treatment
    1 NA