BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1655038 · Received April 6, 2010

    Report

    Report Number
    2183996-2010-00664
    Event Type
    Death
    Date Received
    April 6, 2010
    Date of Event
    March 12, 2010
    Report Date
    March 14, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B) (6) 2010, A COMPANY REP REPORTED THE PT WAS EXPERIENCING ISSUES WITH HER INFUSION DEVICE. THE PT HAD BREAST AND BONE CANCER AND WAS IN CRITICAL CONDITION. UPON FOLLOW UP ON (B) (6) 2010, THE PT'S HUSBAND REPORTED THE PT PASSED AWAY AT 2:00PM TODAY DUE TO MANY CONTRIBUTING FACTORS. HE STATED THE PT'S BLOOD GLUCOSE WAS ELEVATED TO 30 MMOL/L (540 MG/DL). HER NORMAL BLOOD GLUCOSE LEVEL WAS 8 MMOL/L (144 MG/DL). SHE WAS TREATED AT THE HOSPITAL FOR ELEVATED BLOOD GLUCOSE AND ELEVATED SODIUM LEVELS WITH AN IV. HE STATED THE PT BELIEVED THE INFUSION DEVICE WAS NOT FUNCTIONING PROPERLY BECAUSE SHE WAS UNABLE TO LOWER HER BLOOD GLUCOSE. HE ATTEMPTED TO SWITCH HER TO THE BACKUP INFUSION DEVICE BUT WAS UNSUCCESSFUL. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    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 73 YR Death| H| O| R INSULIN| INSULIN INFUSION SET