BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2172365 · Received June 17, 2011

    Report

    Report Number
    2183996-2011-01789
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 29, 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
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011 PT REPORTED SHE DROPPED HER INFUSION DEVICE ABOUT A WEEK AGO ONTO THE BATHROOM FLOOR. PT STATED SHE HAS EXPERIENCED ELEVATED BLOOD GLUCOSE READINGS FOR THE LAST 5-6 DAYS. PT REPORTED HER BLOOD GLUCOSE READINGS ARE GOING UP TO THE 400'S MG/DL. PT'S NORMAL BLOOD GLUCOSE RANGE IS 150-180 MG/DL. PT STATED SHE HAS NOT RECEIVED ANY ERROR MESSAGES. HAD PT DISCONNECT FROM THE INFUSION SITE AND ATTEMPT TO DELIVER A 5.0 UNIT BOLUS OF INSULIN INTO THE AIR. PT REPORTED INSULIN CAME OUT AND THE BOLUS WAS DELIVERED CORRECTLY. PT STATED THE INFUSION DEVICE WAS NOT WORKING PROPERLY OR DELIVERING INSULIN ACCURATELY AFTER BEING DROPPED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT 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 41 YR INSULIN| INSULIN INFUSION SET