BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2143713 · Received June 3, 2011

    Report

    Report Number
    2183996-2011-01556
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 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 Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED SHE IS EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS AND THINKS HER INFUSION DEVICE IS CAUSING IT. PT STATED, SHE WAS GETTING READINGS IN THE 20.0-28 MMOL/L (360-504 MG/DL) RANGE. PT'S NORMAL BLOOD GLUCOSE RANGE IS 6.0-10.0 MMOL/L (108-180 MG/DL). PT REPORTED, SHE CHANGED HER INFUSION SET, CARTRIDGE AND ALSO THE VIAL OF INSULIN SHE WAS USING. PT STATED, HER BLOOD GLUCOSE LEVELS WAS STILL RUNNING HIGH AND SHE WAS USING A SYRINGE TO BRING HER BLOOD GLUCOSE DOWN. PT REPORTED, SHE SWITCHED TO HER BACKUP INFUSION DEVICE USING THE SAME CARTRIDGE OF INSULIN AND HER BLOOD GLUCOSE HAS GONE DOWN. ON FOLLOW UP CALL ON (B)(6) 2011, PT REPORTED, SHE IS CONTINUING TO USE THE ALLEGED INFUSION DEVICE AT THIS TIME. PT STATED, THE DEVICE IS WORKING FOR HER. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE 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 INSULIN INFUSION SET| INSULIN