BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1811143 · Received August 13, 2010

    Report

    Report Number
    2183996-2010-01606
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    July 17, 2010
    Report Date
    July 21, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    Z-1415-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED THE UP BUTTON ON THE INFUSION DEVICE STARTED TO WORK INTERMITTENTLY. THIS WAS NOTICED ON (B)(6) 2010 WHEN ATTEMPTING TO BOLUS FOR LUNCH. UP BUTTON STILL PRODUCES BEEPS AND VIBRATIONS, AND ALL OTHER BUTTONS WORK AS INTENDED. INFUSION DEVICE HAS NOT BEEN DROPPED OR EXPOSED TO WATER OR INSULIN INGRESS. UP BUTTON DOES POP UP AFTER BEING PRESSED AND RELEASED. PT BOLUSES 6 TIMES PER DAY AND HAS USED THIS INFUSION DEVICE SINCE (B)(6) 2007. PT WAS CAMPING ON (B)(6) 2010 WHEN THE UP BUTTON FIRST FAILED TO RESPOND. THIS RESULTED IN ELEVATED BLOOD GLUCOSE OF 360 MG/DL. TARGET BLOOD GLUCOSE IS 65-120 MG/DL. PT SWITCHED TO BACKUP INFUSION DEVICE AND BOLUSED TO CORRECT ELEVATED BLOOD GLUCOSE. PT REMAINS ON BACKUP INFUSION DEVICE. NO ALERTS OR ERRORS WERE RECEIVED. THERE HAS BEEN NO BLOOD, AIR BUBBLES, OR LEAKS IN THE SYSTEM. PT DOES NOT REUSE INSULIN CARTRIDGES. THERE HAVE BEEN NO CONCERNS WITH INFUSION SITES, AND TIME AND BASAL RATES ARE PROGRAMMED CORRECTLY. PT HAS MISSED SOME BOLUSES DUE TO BUTTON FAILURE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. THE 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 45 YR INSULIN| INFUSION SET