BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1890027 · Received November 1, 2010

    Report

    Report Number
    2183996-2010-02181
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, COMPANY REP REPORTED PT WAS HOSPITALIZED WHILE AWAITING A REPLACEMENT INFUSION DEVICE. INFUSION DEVICE WAS REPLACED FOR CARTRIDGE ERROR (E10). F/U WAS COMPLETED WITH PT. PT SWITCHED TO INJECTION THERAPY AFTER CARTRIDGE ERROR (E10) ON INFUSION DEVICE. PT WAS "NOT ABLE TO CONTROL BLOOD GLUCOSE" ON INJECTION THERAPY. PT WAS HOSPITALIZED FOR 2 DAYS AND TREATED WITH AN INSULIN DRIP. BLOOD GLUCOSE ELEVATED ABOVE 500 MG/DL AND PT WAS IN ICU AT HOSPITAL. TARGET BLOOD GLUCOSE IS 80-120 MG/DL. PT WAS VOMITING AND NAUSEOUS DUE TO HYPERGLYCEMIA. PT HAS SINCE REC'D HER REPLACEMENT INFUSION DEVICE AND BLOOD GLUCOSE RETURNED TO NORMAL RANGE.

    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 68 YR Hospitalization| R INSULIN INFUSION SET| INSULIN