BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1000982 · Received February 19, 2008

    Report

    Report Number
    2183996-2008-00138
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 14, 2008
    Report Date
    January 31, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED SHE HAS BEEN HAVING ELEVATED BLOOD GLUCOSE READINGS BETWEEN 232-303 MG/DL SINCE 2008. SHE STATED HER NORMAL RANGE IS 60-120 MG/DL. SHE SAID SHE NOTICED YESTERDAY THE DOWN BUTTON ON HER INSULIN INFUSION DEVICE IS NOT RESPONDING TO PRESSES AND SHE IS CONCERNED THAT SHE MAY NOT HAVE GOTTEN THE CORRECTION BOLUSES SHE THOUGHT SHE WAS GIVING HERSELF. SHE STATED SHE CAN'T ALWAYS WAIT FOR THE CONFIRMATION BEEPS IF SHE IS DRIVING OR IN A LOUD AREA. DURING TROUBLESHOOTING, SHE STATED SHE COULD NOT SEE ANY PHYSICAL DAMAGE TO THE BUTTONS BUT SAID SHE MIGHT HAVE BUMPED HER DEVICE HARD. SHE STATED SHE HAS NEVER CHANGED THE ADAPTER ON HER INFUSION DEVICE. THE PATIENT SAID SHE WENT TO HER ENDOCRINOLOGIST YESTERDAY TO DISCUSS HER ELEVATED READINGS AND HE THOUGHT THE READINGS MAY HAVE BEEN CAUSED BY HER HAVING THE FLU LAST WEEK. THE PRODUCT WAS REPLACED AND REQUESTED TO 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 YR Required Intervention INSULIN| INSULIN INFUSION SET