BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 1080176 · Received July 21, 2008

    Report

    Report Number
    2954323-2008-02291
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 21, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE METER IS RETURNED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING AN ERROR 4 MESSAGE ON HER FREESTYLE BLOOD GLUCOSE METER AND NOT BEING ABLE TO TEST HER BLOOD GLUCOSE. THE CUSTOMER REPORTED CHANGING HER TREATMENT DUE TO NOT BEING ABLE TO TEST. THE CUSTOMER REPORTEDLY FIRST NOTICED THE METER ISSUE IN 2008. THE CUSTOMER REPORTED EXPERIENCING SYMPTOMS OF HYPERGLYCEMIA. SHE WAS REPORTEDLY HOSPITALIZED ELEVEN DAYS IN 2008, AT THE HOSPITAL HER BLOOD GLUCOSE WAS REPORTEDLY OVER 500 MG/DL. THE CUSTOMER REPORTED BEING DIAGNOSED WITH SEVERE HYPERGLYCEMIA AND TREATED WITH INSULIN AND INTRAVENOUS FLUIDS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT 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 076403

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization| R