BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1851569 · Received September 27, 2010

    Report

    Report Number
    2183996-2010-01983
    Event Type
    Injury
    Date Received
    September 27, 2010
    Date of Event
    September 4, 2010
    Report Date
    September 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 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 ELEVATED BLOOD GLUCOSE OVER THE PREVIOUS FEW WEEKS. PT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2010, AND PHYSICIAN REQUESTED TROUBLESHOOTING OF INFUSION DEVICE BEFORE SHE RESTARTS IT. TARGET BLOOD GLUCOSE IS 4-7 MMOL/L (72-126 MG/DL). BLOOD GLUCOSE ON (B)(6) 2010 WAS 8.8 MMOL/L (158.4 MG/DL) AT 8:00 A.M., 13.8 MMOL/L (248.4 MG/DL) AT 12:00 P.M., 14.3 MMOL/L (257.4 MG/DL) AT 6 P.M., AND "HI" AT 9 P.M. PT DELIVERED 5 UNITS OF INSULIN AND CHANGED HER INFUSION SET. BLOOD GLUCOSE ON (B)(6) 2010 WAS 26.2 MMOL/L (471.6 MG/DL) AT 7:30 A.M., "HI" AT 11:00 A.M. AND "HI" AT 11:30 A.M. PT WAS ADMITTED TO THE HOSPITAL AND WAS TREATED WITH INSULIN BY AN IV. PATIENT WAS IN THE HOSPITAL FOR 1 DAY. WHEN INFUSION DEVICE AND INFUSION SET WERE REMOVED, THE INFUSION CANNULA WAS BENT. PT USES A COMPETITOR INFUSION SET AND REPORTED IT WAS "HER FAULT" INFUSION CANNULA WAS BENT. THIS WAS DUE TO IMPROPER INSERTION. THERE WERE NO AIR BUBBLES, LEAKS, OR BLOOD IN THE INFUSION SET OR INSULIN CARTRIDGE. INSULIN CARTRIDGES ARE NOT REUSED. TIME AND BASAL RATES WERE PROGRAMMED CORRECTLY ON INFUSION DEVICE. INSULIN WAS NOT EXPIRED AND THERE WERE NO LIFESTYLE CHANGES. BLOOD GLUCOSE REMAINED ELEVATED AFTER BEING RELEASED FROM HOSPITAL AND WHILE ON INJECTION THERAPY. PT SPOKE WITH CLINICAL SPECIALIST AND F/U WAS COMPLETED. PT RESUMED INFUSION DEVICE THERAPY AND BLOOD GLUCOSE RETURNED TO TARGET RANGE. 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 82 YR Hospitalization| R INSULIN INFUSION SET| INSULIN