BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 1101798 · Received August 5, 2008

    Report

    Report Number
    2954323-2008-02370
    Event Type
    Injury
    Date Received
    August 5, 2008
    Date of Event
    July 4, 2008
    Report Date
    August 5, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTED CUSTOMER RECEIVED A LOW GLUCOSE READING (39 MG/DL) FROM THEIR FREESTYLE METER AND STOPPED TAKING HIS ROUTINE INSULIN MEDICATION. CUSTOMER'S WIFE REPORTED CUSTOMER EXPERIENCED SYMPTOMS OF HALLUCINATION AND DECIDED TO TAKE CUSTOMER TO DEL RALEIGH COMMUNITY HOSP. CUSTOMER'S WIFE REPORTED CUSTOMER WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS AND WAS TREATED WITH INTRAVENOUS SOLUTION AND BLOOD THINNERS; THEN HOSPITALIZED FOR 9 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC., USA NA 0704044

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization