BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1800966 · Received August 11, 2010

    Report

    Report Number
    2183996-2010-01582
    Event Type
    Death
    Date Received
    August 11, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 15, 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
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 7/15/2010, CAREGIVER REPORTED PT WAS ADMITTED TO THE HOSPITAL ON (B)(6)2010. PT EXPERIENCED NORMAL BLOOD GLUCOSE OF 118-130 MG/DL ON THE MORNING OF 7/12/2010. PT'S BLOOD GLUCOSE ELEVATED TO 299 MG/DL LATER IN THE DAY. TREATMENT WAS GIVEN THROUGH INFUSION DEVICE AND BLOOD GLUCOSE LOWERED TO 224 MG/DL. BLOOD GLUCOSE WAS STILL ELEVATED ON (B)(6)2010. AT 8:30 P.M., PT BECAME VERY TIRED AND COULD NOT BREATHE. SHE WAS TAKEN TO THE HOSPITAL. BLOOD GLUCOSE WAS OVER 400 MG/DL. PT WAS DIAGNOSED WITH A URINARY TRACT INFECTION AND PNEUMONIA. CAREGIVER REPORTS BLOOD GLUCOSE WAS ELEVATED DUE TO ILLNESS. TARGET BLOOD GLUCOSE IS 118-140 MG/DL. PT WAS TAKEN OFF INFUSION DEVICE AT THE HOSPITAL; SHE WAS TREATED WITH IV INSULIN DRIP AND BLOOD GLUCOSE REMAINED ELEVATED. THERE WERE NO AIR BUBBLES OR BLOOD IN THE INSULIN CARTRIDGE OR INFUSION TUBING. PT DID NOT REUSE INSULIN CARTRIDGES AND HAD NOT BEEN DISCONNECTED FROM INFUSION SET PRIOR TO HOSPITALIZATION. THERE WAS NO LEAKING OF INSULIN IN SYSTEM AND NO ALARMS OR ERRORS WERE RECEIVED. INSULIN DID DRIP FROM INFUSION TUBING WHEN IT WAS DISCONNECTED FROM HEADSET. TIME AND BASAL RATES WERE SET CORRECTLY. INFUSION SITES WERE ROTATED WELL, AND INSULIN WAS NOT CLOUDY OR EXPIRED. FOLLOW-UP WAS PROVIDED BY COMPANY REPRESENTATIVE. PT WAS PLACED ON LIFE SUPPORT AND WAS REMOVED FROM LIFE SUPPORT ON (B)(6)2010. PT IS DECEASED. PER CAREGIVER, PT HAD AN INFECTION THAT TURNED INTO PNEUMONIA. PT ALSO HAD KIDNEY FAILURE. RETURN KIT WAS SENT TO COMPANY REPRESENTATIVE SO PRODUCT CAN BE RETURNED 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 47 YR Death| H INSULIN| INFUSION SET