BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1820645 · Received August 26, 2010

    Report

    Report Number
    2183996-2010-01645
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 27, 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
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED HER BLOOD GLUCOSE READINGS HAVE BEEN HIGHER THAN NORMAL FOR THE PAST 6 DAYS. PT STATED HER HIGHS HAVE BEEN IN THE 450'S MG/DL. PT'S NORMAL BLOOD GLUCOSE RANGE IS AROUND 180 MG/DL. PT REPORTED SHE HAS CALLED HER PHYSICIAN 6 TIMES IN THE PAST 3 DAYS. PT STATED SHE WAS ASKED TO STOP PUMP THERAPY AND IS NOW CURRENTLY ON INJECTION THERAPY TO CORRECT HER HIGHS. PT REPORTED THE INFUSION ADAPTER WAS LAST REPLACED 1.5 MONTHS AGO. ADVISED TO CHANGE THE ADAPTER EVERY 10TH CARTRIDGE CHANGE. PT STATED SHE HAS CHANGED HER INFUSION SITE 10 TIMES AND THE INFUSION TUBING 8 TIMES IN THE PAST 6 DAYS. PT REPORTED HER INFUSION DEVICE HAS NOT ALARMED WITH AN ERROR MESSAGE TO INDICATE A MALFUNCTION. PT STATED HER BASAL RATES WERE ADJUSTED BY HER PHYSICIAN A MONTH AND A HALF AGO. HAD PT DISCONNECT AT THE SITE AND BOLUS 5.0 UNITS OF INSULIN INTO THE AIR; WAS DELIVERED AND SEEN DRIPPING OUT OF THE TIP OF THE TUBING WITH NO ERROR MESSAGES GIVEN. VERIFIED BOLUS WAS IN THE INFUSION DEVICE MEMORY AND THE CARTRIDGE VOLUME DECREASED. PT STATED SHE FEELS HER BOLUSES ARE NOT COVERING HER MEALS. PT REPORTED SHE WILL SPEAK TO HER PHYSICIAN ABOUT POSSIBLE CAUSES OF THIS. PT STATED SHE IS NOW OFF OF PUMP THERAPY AND ONLY USING INJECTIONS. PT REPORTED THIS HAS BEEN AN ONGOING ISSUE AND REPLACING HER INFUSION DEVICE DID NOT HELP AT ALL AND HER ISSUE CONTINUES. SENDING INFUSION SETS AND CARTRIDGES; PRODUCT WAS REQUESTED TO BE RETURNED 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 39 YR Required Intervention INSULIN INFUSION SET| INSULIN