BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 699501 · Received April 13, 2006

    Report

    Report Number
    2954323-2006-00186
    Event Type
    Malfunction
    Date Received
    April 13, 2006
    Date of Event
    March 18, 2006
    Report Date
    April 12, 2006
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO HAVE ERRATIC READINGS COMPLETED WITHIN 10 MINS (143, 411, 72 7 318 MG/DL0. TESTS WERE PERFORMED ON THE ARM. RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. * 0532034

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN