BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 1083679 · Received July 23, 2008

    Report

    Report Number
    2954323-2008-02315
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE. NOTE: IT SHOULD BE NOTED THAT THIS METER DOES NOT GIVE A NUMERIC VALUE FOR READINGS GREATER THAN 500 MG/DL. A "HI" DISPLAY MESSAGE INDICATES A READING GREATER THAN 500 MG/DL. IN ADDITION, IT SHOULD BE NOTED THAT THE CUSTOMER DID NOT KNOW IF SHE HAD WASHED HER HANDS PRIOR TO TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR FREESTYLE BLOOD GLUCOSE MONITOR WITHIN 10 MINUTES. RESULTS OF 462 MG/DL, 501MG/DL AND 175 MG/DL WERE PLOTTED ON A PARKES ERROR GRID. THE RESULTS 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 BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NA 0635237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA