BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1820619 · Received August 26, 2010

    Report

    Report Number
    2183996-2010-01721
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    August 7, 2010
    Report Date
    August 10, 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
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED BLOOD GLUCOSE OF OVER 500 MG/DL DURING THE WEEKEND OF (B)(6) 2010. PT TOOK HERSELF TO THE EMERGENCY ROOM ON (B)(6) 2010, AND SHE WAS TREATED WITH A SALINE IV. BLOOD GLUCOSE STARTED TO DECREASE AND WAS NEAR 300 MG/DL WHEN DISCHARGED FROM HOSP. PT ALSO EXPERIENCED LOW BLOOD GLUCOSE DURING THE WEEK PRIOR AND THIS CONCERN WAS RESOLVED AFTER PHYSICIAN ADJUSTED BASAL RATES. PT DOES NOT BELIEVE INFUSION DEVICE OR RELATED SUPPLIES WERE THE CAUSE OF HYPERGLYCEMIA. TARGET BLOOD GLUCOSE IS 80-140 MG/DL. NO ERRORS OR ALERTS WERE RECEIVED ON INFUSION DEVICE. PT CHANGES INFUSION SET EVERY 3 DAYS, AND INFUSION SET WAS IN USE FOR 2 DAYS PRIOR TO HOSPITALIZATION. PT DOES NOT KNOW WHEN ADAPTER WAS LAST CHANGED; ADVISED ON MFR RECOMMENDATION. INSULIN CARTRIDGES ARE NOT REUSED. PT WAS USING CORRECT TYPE OF BATTERY AND BATTERY SETTING WAS PROGRAMMED CORRECTLY. TIME AND BASAL RATES WERE PROGRAMMED CORRECTLY. ALL BUTTONS ON INFUSION DEVICE WERE WORKING AS INTENDED. THERE WERE NO LEAKS, BLOCKAGES, OR BLOOD IN THE INFUSION SET. INSULIN WAS NOT EXPIRED AND FLOWED FROM TUBING AS EXPECTED. INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO WATER OR INSULIN INGRESS. BLOOD GLUCOSE HAS RETURNED TO NORMAL RANGE FOLLOWING HOSPITALIZATION. NO PRODUCT WAS REQUESTED 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 50 YR Hospitalization| R INSULIN| INFUSION SET