BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICCU-CHEK SPIRIT

    MDR report key: 2232511 · Received August 25, 2011

    Report

    Report Number
    2183996-2011-02290
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 11, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, NURSE REPORTED THAT PT WAS HOSPITALIZED WITH HYPERGLYCEMIA AND PHYSICIAN BELIEVES THIS WAS CAUSED BY THE INFUSION DEVICE. PT WAS RECEIVING BASAL INSULIN BY THE INFUSION DEVICE AND INSULIN INJECTIONS AT THE TIME OF THE REPORT. HIS MOST RECENT BLOOD GLUCOSE READING WAS 237 MG/DL. NURSE REQUESTED THAT A COMPANY REP EVALUATE THE INFUSION DEVICE, AND SHE CALLED BACK LATER IN THE DAY WHEN PT WAS PRESENT. PT REPORTED HIS BLOOD GLUCOSE ELEVATED TO THE 600 MG/DL RANGE, AND NORMAL BLOOD GLUCOSE IS 120-125 MG/DL. PT WAS TREATED WITH ¿SEVERAL¿ IVS FOR DEHYDRATION AND AN INSULIN DRIP TO DECREASE HIS BLOOD GLUCOSE. NO ERROR MESSAGES WERE RECEIVED ON THE INFUSION DEVICE. THE INFUSION SET IS NOT CHANGED AS RECOMMENDED, AND PT WAS ADVISED ON THE MFR RECOMMENDATIONS. INSULIN CARTRIDGE AND ADAPTER ARE USED WITHIN SPECIFICATIONS. CORRECT TYPE OF BATTERY IS USED IN THE INFUSION DEVICE, AND INSULIN WARMS TO ROOM TEMP BEFORE USE. THERE WAS AN AIR BUBBLE IN THE CARTRIDGE THAT PT PRIMED OUT DURING THE CALL. THERE WAS NO INSULIN LEAKAGE OR BLOOD IN THE SYSTEM. TIME AND BASAL RATES WERE PROGRAMMED CORRECTLY ON THE INFUSION DEVICE. PT DID NOT FORGET TO BOLUS OR HAVE ANY LIFESTYLE CHANGES. INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO WATER OR OTHER LIQUID. COMPANY REP MET WITH PT AND PHYSICIAN ON (B)(6) 2011 AND REPORTED THE INFUSION DEVICE IS FUNCTIONING AS INTENDED. HE BOLUSED 5 UNITS THROUGH THE INFUSION DEVICE, AND INSULIN FLOWED THROUGH THE TUBING AS EXPECTED. F/U WAS COMPLETED WITH THE PT ON (B)(6) 2011. PT WAS DISCHARGED FROM THE HOSP ON (B)(6) 2011, AND PT REPORTED HE DOES NOT BELIEVE THE INFUSION DEVICE CAUSED HYPERGLYCEMIA. PHYSICIAN ADVISED THE HEAT CAUSED PT TO GET SICK AND HAVE HYPERGLYCEMIA. NO PRODUCT WAS RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R INSULIN (DATE OF TX (B)(6))| (DATE OF TX (B)(6))| INSULIN INFUSION SET