BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2090198 · Received May 6, 2011

    Report

    Report Number
    2183996-2011-01319
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 12, 2011
    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
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED THAT SHE EXPERIENCED ELEVATED BLOOD GLUCOSE OF 450 MG/DL AND THAT SHE DOES NOT BELIEVE THE INFUSION DEVICE IS DELIVERING INSULIN CORRECTLY. NORMAL BLOOD GLUCOSE IS 50-70 MG/DL, AND PATIENT BOLUSED 6 UNITS OF INSULIN TO CORRECT HYPERGLYCEMIA. ADAPTER WAS NOT BEING USED PER SPECIFICATION. THERE WAS NO BLOOD OR INSULIN LEAKAGE IN THE SYSTEM. THE INFUSION DEVICE WAS NOT DROPPED, CRACKED, OR EXPOSED TO WATER OR INSULIN INGRESS. PATIENT REPORTED SHE WAS ALSO HOSPITALIZED DUE TO HYPERGLYCEMIA. SHE REPORTED BLOOD GLUCOSE CONTINUED TO RISE DESPITE DELIVERING BOLUSES. BLOOD GLUCOSE WAS 700 MG/DL AT THE HOSPITAL, AND PATIENT WAS VOMITING. PATIENT WAS ADMITTED TO THE HOSPITAL FOR 3 DAYS, AND SHE REMAINED ON THE INFUSION DEVICE AND ALSO RECEIVED INSULIN INJECTIONS. THIS OCCURRED IN (B)(6), 2011. PATIENT WAS NOT ON INFUSION DEVICE THERAPY AT THE TIME OF THE REPORT AND ADVISED SHE WOULD CHANGE THE ADAPTER AND BATTERY AND RESUME USE OF HER PRIMARY INFUSION DEVICE. FOLLOW-UP WAS COMPLETED ON (B)(6) 2011, AND PATIENT REPORTED HER BLOOD GLUCOSE WAS "EXTREMELY HIGH" AFTER THE BATTERY AND ADAPTER WERE CHANGED. SHE WAS UNABLE TO CONTROL HER BLOOD GLUCOSE, SO SHE SWITCHED TO HER BACKUP INFUSION DEVICE. BLOOD GLUCOSE HAS BEEN "GREAT EVER SINCE." NO ERROR MESSAGES WERE RECEIVED ON THE INFUSION DEVICE. PATIENT REPORTED THE PISTON ROD DOES MOVE DURING BOLUS DELIVERY, BUT SHE DOES NOT FEEL LIKE SHE IS RECEIVING THE BASAL RATES. INFUSION DEVICE WAS REPLACED AND REQUESTED 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 49 YR Hospitalization| R INSULIN (DATE OF TX: 3 DAYS IN (B)(6))| INSULIN INFUSION SET| (DATE OF TX: 3 DAYS IN (B)(6))