BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 2081477 · Received April 12, 2011

    Report

    Report Number
    2183996-2011-00944
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 13, 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, FATHER REPORTED THE INFUSION DEVICE PISTON ROD WAS BENT AND THIS CAUSED INSULIN TO LEAK INTO THE CARTRIDGE COMPARTMENT. PT EXPERIENCED ELEVATED BLOOD GLUCOSE IN THE MID-200'S MG/DL AS A RESULT, AND TARGET BLOOD GLUCOSE IS 80-180 MG/DL. PT CORRECTED HYPERGLYCEMIA BY DELIVERING BOLUSES THROUGH THE INFUSION DEVICE. WHEN THE CARTRIDGE WAS REMOVED ON THE DAY OF THE REPORT, PT NOTICED A LOT OF INSULIN HAD SPILLED INSIDE OF THE INFUSION DEVICE. PT POURED THE INSULIN OUT OF THE CARTRIDGE COMPARTMENT. THE CARTRIDGE PLUNGER WAS NOT STUCK ON THE PISTON ROD, AND THERE WERE NO VISIBLE LEAKS TO CRACKS IN THE CARTRIDGE. THE BLACK PLUNGER HOLDER OF THE PISTON ROD WOBBLED. INFUSION DEVICE AND ADAPTER WERE REPLACED AND REQUESTED FOR EVAL. THE CARTRIDGE WAS ALSO REQUESTED FOR EVAL. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR INSULIN INFUSION DEVICE| INSULIN INFUSION SET| INSULIN