BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1944481 · Received December 28, 2010

    Report

    Report Number
    2183996-2010-02671
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    October 13, 2010
    Report Date
    December 13, 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, PT REPORTED HAVING CONTINUING ISSUES WITH ELEVATED BLOOD GLUCOSE LEVELS. PT STATED HER BLOOD GLUCOSE GOT A LITTLE BETTER BUT WITHIN THE LAST 3-4 WEEKS, IT HAS BEEN OUT OF CONTROL. PT REPORTED HER BLOOD GLUCOSE LEVEL HAS BEEN UP IN THE 400'S MG/DL. PT'S NORMAL BLOOD GLUCOSE RANGE IS AROUND 150 MG/DL. PT STATED SHE HAS BEEN TREATING HERSELF WITH INSULIN INJECTIONS AND THIS IS THE ONLY THING THAT WILL LOWER HER BLOOD GLUCOSE. PT REPORTED SHE HAS DISCONNECTED THE INFUSION TUBING AND ATTEMPTED TO BOLUS; THE TUBING AND INFUSION DEVICE ARE DELIVERING A BOLUS, BUT THE INFUSION DEVICE IS NOT DELIVERING HER HOURLY BASAL RATES. PT STATED SHE HAS TAKEN THE INFUSION DEVICE OFF AND LISTENED AND WATCHED. PT REPORTED THE INFUSION DEVICE WASN'T MAKING THE NOISE IT USUALLY MAKES EVERY 3 MINUTES TO DELIVER ANY BOLUSES. PT REPORTED SHE FEELS SHE HAS NOT BEEN GETTING THE BOLUSES AND THIS IS WHY HER BLOOD GLUCOSE LEVEL HAS BEEN ELEVATED. PT STATED THE INFUSION TUBING IS USUALLY CHANGED WEEKLY BUT SHE HAS BEEN CHANGING IT OFTEN TRYING TO LOWER HER BLOOD GLUCOSE READINGS. PT REPORTED THE INFUSION ADAPTER HASN'T BEEN CHANGED SINCE (B)(6) AND SHE DOESN'T USUALLY CHANGE IT EVERY 10 CARTRIDGE CHANGES. ADVISED PT IT IS VERY IMPORTANT TO DO THIS. PT STATED SHE WILL DISCONNECT AND BOLUS; INSULIN WILL EMERGE. ADVISED PT TO TRY HER BACK UP INFUSION DEVICE; PT STATED SHE HAS LOST THE BACKUP INFUSION DEVICE. 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 ALLEGED 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 30 YR Required Intervention INSULIN INFUSION SET| INSULIN