BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 1781770 · Received June 25, 2007

    Report

    Report Number
    2954323-2007-11147
    Event Type
    Malfunction
    Date Received
    June 25, 2007
    Date of Event
    May 27, 2007
    Report Date
    June 25, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. 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 BLOOD GLUCOSE MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF 261 MG/DL AND 41 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. ADDITIONALLY, THE CUSTOMER REPORTED THAT HE HAD DIAPHORESIS. THERE WAS NO REPORT OF THIRD PARTY MEDICAL INTERVENTION, DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC, USA NA 0635824

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK