BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2833331 · Received October 26, 2012

    Report

    Report Number
    2183996-2012-01662
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 11, 2012
    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
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, PT REPORTED IT TOOK HER INFUSION DEVICE 50 UNITS OF INSULIN TO PRIME OUT THE INFUSION SET TUBING. PT STATED HER BLOOD GLUCOSE LEVEL WAS 454 MG/DL TODAY AND SHE HAS CHANGED TO HER BACKUP INFUSION DEVICE. PT REPORTED HER BLOOD GLUCOSE LEVEL WAS 375 MG/DL THIS MORNING AND SHE TOOK 9.0 UNITS OF THE INSULIN. PT REPORTED HER BLOOD GLUCOSE LEVEL WAS 454 MG/DL AT LUNCH TIME WITHOUT EATING SINCE BREAKFAST THIS MORNING. PT STATED SHE TOOK 5 UNITS WITHOUT EATING ANYTHING FOR LUNCH. PT IS CURRENTLY ON HER BACKUP INFUSION DEVICE. PT REPORTED SHE HAD A BLOOD GLUCOSE READING BACK DOWN. PT'S NORMAL BLOOD GLUCOSE RANGE IS 100-130 MG/DL. PT REPORTED SHE DIDN'T NEED ANY OUTSIDE ASSISTANCE FOR EITHER OF THE ELEVATED BLOOD GLUCOSE READINGS. PT STATED SHE CHANGED HER INSULIN CARTRIDGE ON MONDAY AND THE BATTERY LAST WEEK. PT REPORTED THE INFUSION DEVICE DID NOT DISPLAY ANY ERROR MESSAGES. PT STATED SHE HAS EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS SINCE MONDAY OF THIS WEEK. PT REPORTED THE ADAPTER WAS CHANGED IN JUNE; ADVISED TO CHANGE WITH EVERY 10TH CARTRIDGE CHANGE. PT STATED THERE IS INSULIN DRIPPING AFTER PRIMING. ON F/U CALL ON (B)(6) 2012 PT REPORTED HER BLOOD GLUCOSE LEVELS HAVE COME BACK DOWN TO NORMAL WHILE USING THE BACKUP INFUSION DEVICE AND EVERYTHING IS WORKING AS INTENDED. PT STATED SHE FELT LIKE SHE WAS NOT GETTING ENOUGH INSULIN FROM THE 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 INFUSION DEVICE, INFUSION SET, ADAPTER AND INSULIN CARTRIDGE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR INSULIN INFUSION PUMP| RELATED ACCESSORIES| INSULIN