BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2190608 · Received July 27, 2011

    Report

    Report Number
    2183996-2011-02112
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED HE DOESN'T FEEL THAT HE IS GETTING HIS INSULIN DELIVERED CORRECTLY FROM THE INFUSION DEVICE. PT STATED THE OTHER NIGHT HIS BLOOD GLUCOSE LEVEL WAS 450 MG/DL, HE BOLUSED AND THEN WENT TO BED. PT REPORTED HE WOKE UP IN THE MORNING AND HIS BLOOD GLUCOSE LEVEL WAS STILL ELEVATED AT 350 MG/DL. PT STATED HE DOESN'T THINK HE IS GETTING HIS INSULIN ALL OF THE TIME. PT REPORTED THIS ISSUE HAS BEEN GOING ON FOR THE LAST 4-5 DAYS. PT REPORTED HE HAS NOT RECEIVED ALARMS THAT HE WASN'T GETTING INSULIN, HE CAN JUST TELL FROM HIS BLOOD GLUCOSE LEVEL. PT'S NORMAL BLOOD GLUCOSE LEVEL IS 150-300 MG/DL. PT STATED WHEN HE WOKE UP THAT MORNING HE BOLUSED AGAIN AND IT DID BRING HIS BLOOD GLUCOSE LEVEL BACK DOWN TO NORMAL. PT REPORTED THE INFUSION ADAPTER HAS NEVER BEEN CHANGED. ADVISED TO CHANGE THE ADAPTER WITH EVERY 10TH CARTRIDGE CHANGE. PT STATED HE FILLS THE INSULIN CARTRIDGE WITH COLD INSULIN. ADVISED PT REGARDING USING COLD INSULIN. PT REPORTED THE BASAL RATES ON THE INFUSION DEVICE ARE SET CORRECTLY BUT THE TIME AND DATE ARE NOT. ASSISTED PT WITH SETTING THE CORRECT DATE AND TIME. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE SUSPECT PRODUCT 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 32 YR INSULIN INFUSION SET| INSULIN