BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1890019 · Received November 1, 2010

    Report

    Report Number
    2183996-2010-02204
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    October 17, 2010
    Report Date
    October 18, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED HYPERGLYCEMIA REQUIRING TREATMENT AT HOSPITAL. PT CHANGED INSULIN CARTRIDGE AND INFUSION SET ON (B)(6) 2010. BLOOD GLUCOSE ELEVATED TO 550 MG/DL THAT EVENING. PT DID NOT LOSE CONSCIOUSNESS BUT DID NOT REQUIRE MEDICAL ATTENTION. PARAMEDICS WERE CALLED AND TRANSPORTED PT TO HOSPITAL. PT WAS TAKEN OFF INFUSION DEVICE AND PLACED ON AN IV. HE WAS ALSO TREATED WITH AN INSULIN PEN, WHICH LOWERED BLOOD GLUCOSE TO 225 MG/DL BY MORNING OF REPORT. TARGET BLOOD GLUCOSE IS 90- 200 MG/DL. PT HAD STARTED INFUSION DEVICE ON (B)(6) 2010 AFTER BEING HOSPITALIZED FOR 7 WEEKS FOR KNEE SURGERY. PT REPORTED A COUPLE DROPS OF INSULIN FLOWED DURING PRIME PROCEDURE. PT PRIMED ANOTHER 25 UNITS AND THE SAME ISSUE OCCURRED. NO ERROR MESSAGES WERE REC'D AND INFUSION DEVICE BUTTONS FUNCTIONED AS INTENDED. THERE WERE NO AIR BUBBLES IN THE SYSTEM. INFUSION NEEDLE IS CHANGED EVERY 2 DAYS AND TUBING EVERY 4 DAYS. ADVISED ON MANUFACTURER RECOMMENDATION FOR ADAPTER. PT DOES NOT KNOW WHEN ADAPTER WAS LAST CHANGED. INSULIN CARTRIDGES ARE NOT REUSED. BATTERY WAS OF CORRECT TYPE AND SETTING WAS PROGRAMMED CORRECTLY. BASAL RATES WERE CORRECT. DAILY TOTALS FOR INSULIN DELIVERY WERE 0.0 ON (B)(6) 2010 AND (B)(6) 2010. PT DID NOT LOOK AT INFUSION DEVICE THOSE DAYS AND COULD NOT BE CERTAIN IF INFUSION DEVICE WAS IN RUN MODE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. F/U WAS COMPLETED. PT REPORTED BLOOD GLUCOSE RETURNED TO NORMAL RANGE SINCE INFUSION DEVICE WAS REPLACED IN INITIAL REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R INSULIN| INSULIN INFUSION SET