BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1780825 · Received July 27, 2010

    Report

    Report Number
    2183996-2010-01474
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 21, 2010
    Report Date
    June 26, 2010
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT'S CERTIFIED DIABETES EDUCATOR (CDE) REPORTED THE PT WAS IN THE HOSP FOR DKA AND WILL BE RELEASED TODAY. CDE REPORTED THE PT HAS NOT BEEN WEARING THE INFUSION DEVICE RECENTLY AND WENT INTO DKA. CDE STATED PT HAD BEEN RECEIVING E6 (MECHANICAL ERROR) ALERTS ON THE PRIMARY INFUSION DEVICE, SWITCHED TO HIS BACKUP INFUSION DEVICE SEVERAL TIMES FOR EXTENDED AMOUNTS OF TIME AND NOW THE BACKUP INFUSION DEVICE HAS REACHED END OF LIFE. CDE REPORTED THE PT WAS UNABLE TO CLEAR THE E6 ON THE PRIMARY INFUSION DEVICE. ON CALLBACK ON (B)(6) 2010, CDE CALLED TO CHECK ON THE STATUS OF PT'S INFUSION DEVICE. ON FOLLOW-UP CALL ON (B)(6) 2010 TO PT, PT'S GIRLFRIEND REPORTED PT WAS ADMITTED TO THE HOSP ON (B)(6) 2010 WITH DKA. GIRLFRIEND STATED PT WAS VOMITING AND HAD CONSISTENT ELEVATED BLOOD GLUCOSE READINGS OF "HI" AND HAD BEEN OFF OF THE INFUSION DEVICE FOR 2 DAYS PRIOR TO BEING HOSPITALIZED. PT'S NORMAL BLOOD GLUCOSE READINGS ARE AROUND 180 MG/DL. GIRLFRIEND REPORTED PT HAD BEEN WEARING BACKUP INFUSION DEVICE WHICH HAD REACHED 'END OF OPERATION' ON (B)(6) 2010. GIRLFRIEND STATED PT HAD BEEN WEARING BACKUP INFUSION DEVICE DUE TO REPEATED E6 ERRORS ON HIS PRIMARY INFUSION DEVICE. REPLACEMENT INFUSION DEVICE HAD BEEN SENT. ADVISED TO CHANGE INFUSION ADAPTER EVERY 10TH INSULIN CARTRIDGE CHANGE. ASSISTED WITH SETTING TIME/DATE. ADVISED TO ALWAYS ALLOW INSULIN TO WARM TO ROOM TEMPERATURE PRIOR TO INSTALL. ADVISED ON PROPER BATTERY TYPE TO USE. 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| R INSULIN| INSULIN INFUSION SET