BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1890043 · Received November 1, 2010

    Report

    Report Number
    2183996-2010-02186
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    August 1, 2010
    Report Date
    October 19, 2010
    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
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED HYPERGLYCEMIA OVER THE PREVIOUS 2 MONTHS. PATIENT REPORTED INSULIN "BACKS UP" WHERE THE INFUSION TUBING CONNECTS TO THE INFUSION DEVICE. PATIENT DISCONNECTS INFUSION TUBING FROM THE INFUSION DEVICE WHEN HER BLOOD GLUCOSE IS ELEVATED, AND SHE WILL SEE AIR BUBBLES AND INSULIN AT THE CONNECTION. INFUSION SET AND INSULIN CARTRIDGE WERE CHANGED ON (B)(6) 2010. WHEN PATIENT RETURNED HOME LATER THAT DAY, BLOOD GLUCOSE WAS 587 MG/DL. PATIENT DISCONNECTED FROM INFUSION DEVICE AND STARTED INJECTION THERAPY. PATIENT HAS REMAINED ON INJECTION THERAPY AND BLOOD GLUCOSE HAS BEEN "FINE." TARGET BLOOD GLUCOSE IS 80 MG/DL. INFUSION TUBING IS CHANGED EVERY 3-4 DAYS AND INSULIN CARTRIDGE IS PARTIALLY FILLED TO 200 UNITS. PATIENT ADJUSTS PISTON ROD FORWARD TO 200 UNITS. PATIENT DOES NOT OVER OR UNDER-TIGHTEN THE LUER LOCK CONNECTION. INFUSION DEVICE HAS NOT BEEN DROPPED OR EXPOSED TO WATER OR INSULIN INGRESS. CORRECT TYPE OF BATTERY IS USED IN INFUSION DEVICE. TIME AND BASAL RATES ARE PROGRAMMED CORRECTLY. INSULIN IS NOT EXPIRED AND IS WARMED TO ROOM TEMPERATURE BEFORE CARTRIDGE IS FILLED. THERE WERE NO CHANGES TO DIET, EXERCISE, OR MEDICATION. PATIENT HAS HAD SEVERAL BLADDER INFECTIONS BUT REPORTED THIS WAS DUE TO HYPERGLYCEMIA. PATIENT DID SEEK TREATMENT AT URGENT CARE FACILITY ON ONE OCCASION. BLOOD GLUCOSE WAS APPROXIMATELY 700 MG/DL. PATIENT WAS GIVEN AN INJECTION OF INSULIN AND MONITORED FOR A FEW HOURS. THIS OCCURRED IN EARLY (B)(6), 2010. PATIENT REPORTED A LACK OF CONFIDENCE IN INFUSION DEVICE AND THAT BLOOD GLUCOSE HAS BEEN "OUT OF CONTROL" WHILE ON INFUSION DEVICE. INFUSION DEVICE AND INFUSION SET WERE REPLACED AND REQUESTED FOR EVALUATION.

    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 36 YR Required Intervention INSULIN| INSULIN INFUSION SET