BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 1002468 · Received February 21, 2008

    Report

    Report Number
    2954323-2008-00852
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 22, 2008
    Report Date
    February 21, 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 DAUGHTER REPORTED CUSTOMER RECEIVED INACCURATE HIGH GLUCOSE READING (143 MG/DL) FROM THEIR FREESTYLE METER. CUSTOMER'S DAUGHTER REPORTED CUSTOMER EXPERIENCED SYMPTOMS OF "SLURRED SPEECH, COULD NOT FOCUS, SAGGING MOUTH, RESTLESS LEGS, ARMS WAGGING AND COULD NOT TALK". PARAMEDICS WERE CALLED AND OBTAINED A READING OF 47 MG/DL WITH THEIR HCP METER AND TREATED CUSTOMER WITH A SHOT OF UNK MEDICATION TO RAISE HER BLOOD SUGAR. CUSTOMER WAS THEN TRANSPORTED CUSTOMER TO COPLEY HOSPITAL WHERE SHE WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND BEING TREATED WITH APPLE JUICE AND CRACKERS, AND HER BLOOD SUGAR LEVEL WENT BACK UP TO 135 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. USA NA 0608048

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization| R