BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2110229 · Received May 20, 2011

    Report

    Report Number
    2183996-2011-01448
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 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
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT'S MOTHER REPORTED THAT THE PT'S PRIMARY PUMP FAILED RESULTING IN HIGH BLOOD SUGAR. MOTHER STATED THE PT'S BLOOD GLUCOSE WAS OVER 200 MG/DL. MOTHER REPORTED THE PT ATTEMPTED TO DELIVER A BOLUS BUT WAS UNABLE TO. PT SWITCHED TO HER BACKUP INFUSION DEVICE. IT WAS NOT KNOWN IF THE PT'S BLOOD GLUCOSE RETURNED TO NORMAL AFTER SWITCHING TO THE BACKUP INFUSION DEVICE. MOTHER DID NOT HAVE DETAIL ABOUT WHAT WAS WRONG WITH THE INFUSION DEVICE. ON F/U, PT REPORTED WHILE THE INFUSION DEVICE WAS IN THE RUN MODE, THE DEVICE BEEPED, VIBRATED AND THE BACKLIGHT CAME ON, BUT NO ERROR MESSAGE DISPLAYED. PT STATED THE INFUSION DEVICE ATTEMPTED TO DELIVER A BOLUS OF 0.5 UNITS OF INSULIN WITHOUT ANY BUTTONS BEING PRESSED. PT REPORTED SHE ATTEMPTED TO CANCEL THE BOLUS, BUT NONE OF THE BUTTONS WORKED. PT STATED HER BLOOD GLUCOSE LEVEL WAS 226 MG/DL. PT'S NORMAL BLOOD GLUCOSE RANGE IS 130-150 MG/DL. PT REPORTED SHE SWITCHED TO HER BACKUP INFUSION DEVICE AND DELIVERED A CORRECTION BOLUS. PT STATED ABOUT 20 MINUTES AFTER THE INCIDENT, SHE CHECKED THE BASAL RATES ON THE ALLEGED INFUSION DEVICE AND ALL OF THE BUTTONS FUNCTIONED PROPERLY. PT REPORTED WHEN THE INFUSION DEVICE BEEPED, VIBRATED AND THE BACKLIGHT CAME ON, THE DISPLAY SHOWED THE CLOCK AND HER BASAL RATE FOR THAT HOUR; NO ERROR MESSAGE DISPLAYED ON THE DEVICE. PT STATED THE INFUSION DEVICE FELL INTO A POOL ON (B)(6) 2011, AND WAS IMMEDIATELY PULLED OUT. PT REPORTED SHE DID NOT REMOVE THE INSULIN CARTRIDGE TO CHECK FOR MOISTURE INSIDE 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 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 INSULIN INFUSION SET| INSULIN