BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2002149 · Received February 4, 2011

    Report

    Report Number
    2183996-2011-00111
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 19, 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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT'S HUSBAND REPORTED PATIENT'S BLOOD GLUCOSE WAS ELEVATED AROUND 500 MG/DL FOR ABOUT A WEEK. HUSBAND STATED THEY SWITCHED TO THE BACKUP INFUSION DEVICE AND IMMEDIATELY HER BLOOD GLUCOSE REGULATED. PATIENT'S TARGET BLOOD GLUCOSE IS 200 MG/DL, BUT HER DOCTOR WANTS HER BLOOD GLUCOSE BETWEEN 100-150 MG/DL. HUSBAND REPORTED, PATIENT HAD NOT RECEIVED ANY ALERTS OR ERRORS THAT WERE UNUSUAL. HUSBAND STATED, HE CHANGED HER INFUSION SITE AND INFUSION TUBING EVERY DAY SEVERAL TIMES TO SEE IF THE BLOOD GLUCOSE WOULD LOWER. HUSBAND REPORTED, THE INFUSION ADAPTER WAS NOT CHANGED VERY OFTEN. ADVISED TO CHANGE ADAPTER EVERY 10TH CARTRIDGE CHANGE. HUSBAND STATED, HE DISCONNECTED THE INFUSION TUBING AND PRIMED; INSULIN DID DRIP FROM THE TUBING. HUSBAND REPORTED, WHEN HIS WIFE DISCONNECTED AND BOLUSED, INSULIN DID NOT EMERGE. HUSBAND STATED, THE INFUSION DEVICE HAD BEEN DROPPED ONCE BUT NOT IN THE PAST 48 HOURS. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE SUSPECT PRODUCT 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 50 YR INSULIN INFUSION SET| INSULIN