BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2143494 · Received June 2, 2011

    Report

    Report Number
    2183996-2011-01524
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    June 1, 2010
    Report Date
    May 4, 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, THE PT'S HUSBAND REPORTED, THE PT HAS BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE OF OVER 300 MG/DL LATELY. HER NORMAL BLOOD GLUCOSE RANGE IS 120-150 MG/DL. HE STATED THAT WHEN THE PT'S BLOOD GLUCOSE WAS ELEVATED SHE WOULD CHANGE THE INFUSION SET AND FIND THE CANNULA WAS BENT. THE PT HAS ALSO EXPERIENCED ELEVATED BLOOD GLUCOSE WITH OTHER INFUSION SET TYPES. HE STATED ELEVATED BLOOD GLUCOSE HAS BEEN ONGOING FOR THE PAST YR AND BELIEVES THE INFUSION DEVICE IS NOT PROPERLY DELIVERING BASAL RATES. HE STATED THE BASAL RATE HAS BEEN ADJUSTED SEVERAL TIMES WITH NO RESULT. THE INFUSION SITE AND TUBING IS CHANGED EVERY 3-4 DAYS, THE CARTRIDGE IS CHANGED EVERY WEEK, AND THE ADAPTER HAD NOT BEEN CHANGED IN 6-8 MONTHS. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE ALLEGED INFUSION SETS WERE DISCARDED. THE INFUSION DEVICE WAS REPLACED. THE INFUSION DEVICE, CARTRIDGE, AND ADAPTER WERE REQUESTED TO BE RETURNED FOR EVAL.

    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 43 YR INSULIN INFUSION SET| INSULIN