BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2231666 · Received July 22, 2011

    Report

    Report Number
    2183996-2011-02063
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THE INFUSION DEVICE DISPLAYED E10 CARTRIDGE DURING A CARTRIDGE CHANGE AND THAT HE DOES NOT FEEL THE INFUSION DEVICE DELIVERS INSULIN CORRECTLY. THIS HAS RESULTED IN ELEVATED BLOOD GLUCOSE IN THE 400 MG/DL RANGE, AND NORMAL BLOOD GLUCOSE IS NEAR 150 MG/DL. PT EXPERIENCED INCREASED THIRST DUE TO HYPERGLYCEMIA AND DELIVERED BOLUSES THROUGH THE INFUSION DEVICE AS TREATMENT. NO ERRORS WERE REC'D ON THE INFUSION DEVICE. THE ADAPTER AND BATTERY WERE USED PER SPECIFICATION. PT CHANGES THE INFUSION HEADSET EVERY 3-4 DAYS AND THE TUBING EVERY 4-5 DAYS. THERE HAS BEEN NO INSULIN LEAKAGE, BLOOD, OR AIR BUBBLES IN THE SYSTEM. TIME AND BASAL RATES WERE PROGRAMMED CORRECTLY. PT DID NOT EXPERIENCE ANY LIFESTYLE CHANGES. INFUSION DEVICE WAS NOT DROPPED, CRACKED, OR EXPOSED TO WATER OR OTHER LIQUIDS. INFUSION DEVICE, BATTERY, BATTERY COVER, ADAPTER, INFUSION SET, AND CARTRIDGE WERE REQUESTED FOR EVAL. INFUSION DEVICE WAS REPLACED. PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    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 34 YR INSULIN INFUSION SET| INSULIN