BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2031008 · Received March 16, 2011

    Report

    Report Number
    2183996-2011-00538
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    January 3, 2011
    Report Date
    February 26, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED SHE WENT INTO THE HOSPITAL FOR KETOACIDOSIS. PT STATED SHE HAS BEEN HAVING ELEVATED BLOOD GLUCOSE DUE TO HER HOME SITUATION. PT REPORTED HER BLOOD GLUCOSE WAS UP IN THE 500'S MG/DL. PT'S NORMAL BLOOD GLUCOSE RANGE IS 60-180 MG/DL. PT STATED SHE ALSO REPORTED RECEIVING AN OCCLUSION. PT STATED SHE BEGAN THROWING UP AND WAS TAKEN TO THE HOSPITAL. PT REPORTED SHE WAS IN THE HOSPITAL FOR ONE WEEK. PT STATED THEY TOOK HER OFF OF THE INFUSION DEVICE AND REGULATED HER BLOOD GLUCOSE. PT STATED WHEN SHE LEFT THE HOSPITAL, SHE WENT BACK ON THE INFUSION DEVICE AND EVERYTHING WORKED FINE. PT REPORTED HER BLOOD GLUCOSE REMAINED NORMAL. PT STATED HER INFUSION ADAPTER HAS NEVER BEEN CHANGED. ADVISED PT TO CHANGE THE ADAPTER EVERY 10 INSULIN CARTRIDGE CHANGE. PT NO LONGER USES THAT TYPE OF INFUSION SETS. NO PRODUCT RETURN WAS REQUESTED.

    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 Hospitalization| O| R INSULIN ((B)(6))| INSULIN INFUSION SET ((B)(6))