BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2071803 · Received April 21, 2011

    Report

    Report Number
    2183996-2011-01175
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    March 19, 2011
    Report Date
    March 30, 2011
    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
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THAT SHE WAS HOSPITALIZED 2 TIMES IN THE PAST 2 WEEKS FOR HYPERGLYCEMIA AND THAT SHE DOES NOT BELIEVE HER INFUSION DEVICE IS FUNCTIONING PROPERLY. PT REPORTED SHE DOES NOT RECEIVE INTENDED BOLUSES DUE TO FREQUENT ALARMS ON THE INFUSION DEVICE. PT BELIEVES THE INFUSION DEVICE GAVE E3 AUTOMATIC OFF AND AN E8 POWER INTERRUPT ERRORS. THE FIRST HOSPITALIZATION WAS FOR A TOTAL OF 6 DAYS, AND PT HAD BEEN IN THE HOSPITAL FOR 3 DAYS AT THE TIME OF THE REPORT. BLOOD GLUCOSE ELEVATED TO THE 330 MG/DL RANGE, AND NORMAL BLOOD GLUCOSE IS 78-100 MG/DL. PT WAS TREATED WITH AN INSULIN DRIP AT THE HOSPITAL. INFUSION DEVICE WAS DROPPED A WEEK AGO, BUT IT WAS NOT CRACKED. PT SWITCHED TO HER BACKUP INFUSION DEVICE DURING THE TROUBLESHOOTING CALL. INFUSION DEVICE WAS NOT EXPOSED TO WATER OR OTHER LIQUIDS. INFUSION DEVICE, CARTRIDGE, AND ADAPTER WERE REPLACED AND REQUESTED FOR EVAL. THE INFUSION SETS WERE DISCARDED AND WILL NOT 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 34 YR Hospitalization| R INSULIN, (DATE OF TX: (B)(6))| INSULIN INFUSION SET:| (DATE OF TX: (B)(6))