BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 1011213 · Received May 11, 2007

    Report

    Report Number
    2954323-2007-07691
    Event Type
    Malfunction
    Date Received
    May 11, 2007
    Date of Event
    April 12, 2007
    Report Date
    May 11, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. FOLLOW UP REPORT WILL BE SUBMITTED IF THE PRODUCT IS RETURNED FOR EVALUATION. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE ADC FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, THE UNIT OF MEASUREMENT SETTING HAD CHANGED FROM MG/DL TO MMOL/L ON HER UNLOCKED FREESTYLE METER. SHE REPORTED A READING OF 29.5 AND THINKING IT WAS 295 MG/DL, SHE WENT TO HER DOCTOR. HE TESTED HER GLUCOSE AND RECEIVED A READING OF 327 MG/DL. SHE WAS DIAGNOSED WITH SEVERE HYPERGLYCEMIA AND WAS PRESCRIBED INSULIN. 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 NI 0627004

    Patients

    Seq Age Sex Outcome Treatment
    1 NI