BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1202747 · Received October 17, 2008

    Report

    Report Number
    2183996-2008-01605
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 1, 2008
    Report Date
    October 13, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT'S MOTHER REPORTED THAT THE PATIENT WAS HOSPITALIZED "THE LAST PART OF LAST MONTH." THE PATIENT WAS AT WORK AND BEGAN TO FEEL LIGHT HEADED, DIZZY, WITH CHEST PAINS, AND DIFFICULTY BREATHING. THE MOTHER TOOK THE PATIENT TO THE HOSPITAL AND THE PATIENT'S BLOOD GLUCOSE MEASURED 719 MG/DL. SHE WAS TREATED WITH AN IV AND "MANUAL SHOTS EVERY SO OFTEN." SHE REMAINED IN THE HOSPITAL FOR 2-4 DAYS. THE PATIENT RESUMED USE OF THE INFUSION DEVICE AFTER RETURNING HOME AND SHE HAS EXPERIENCED ELEVATED BLOOD GLUCOSE OF 200 MG/DL "BUT NOT EXTREMELY HIGH." THE PATIENT'S MOTHER WAS NOT ABLE TO PROVIDE EXACT DATES OR BLOOD GLUCOSE VALUES. THE MOTHER ATTRIBUTES ELEVATED BLOOD GLUCOSE TO THE PATIENT'S DIET. SHE STATED THAT THE PATIENT "GETS SUGAR URGES, DRINKS POP, EATS COOKIES. SHE DOES WHAT SHE WANTS TO DO." NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R INSULIN| INSULIN INFUSION SET