BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1017446 · Received March 17, 2008

    Report

    Report Number
    2954323-2008-01085
    Event Type
    Malfunction
    Date Received
    March 17, 2008
    Date of Event
    February 18, 2008
    Report Date
    March 17, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PROD HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A F/U REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR FREESTYLE FLASH BLOOD GLUCOSE MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF (333, 216, 61, 89, 152, 136, 114, 164, 14 AND 41 MG/DL) WITHIN 10 MINS. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONES SHOWING THE DIFFERENCE IIN 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 FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. NA 0727532

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK