BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 657927 · Received December 30, 2005

    Report

    Report Number
    2954323-2005-00768
    Event Type
    Malfunction
    Date Received
    December 30, 2005
    Date of Event
    December 9, 2005
    Report Date
    December 30, 2005
    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 RECEIVING ERRATIC READINGS. IN BLOOD GLUCOSE TESTS, CUSTOMER RECEIVED READINGS OF 67, 71, 73, 233, 142 MG/DL AND 419 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. CUSTOMER REPORTED HAVING SYMPTOMS OF HYPOGLYCEMIA: SHAKY, SWEATY AND NAUSEOUS IN THE STOMACH. CUSTOMER TOOK THREE GLUCOSE TABLETS TO STABILIZE HIMSELF. CUSTOMER THEN BECAME WEAKER AND THE PARAMEDICS WERE CALLED. THE CUSTOMER WAS TRANSPORTED TO THE HOSPITAL WHERE HE WAS MONITORED FOR THE NEXT FOUR HOURS AS HE STABILIZED. CUSTOMER REPORTED TAKING 70 UNITS OF NOVOLOG BEFORE EATING LUNCH ON THIS DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. NA 0527208

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R