BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2171085 · Received July 8, 2011

    Report

    Report Number
    2183996-2011-01980
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT'S MOTHER REPORTED THE BOLUS DELIVERY OF THE INFUSION DEVICE IS FAULTY. WHEN MOTHER PROGRAMS A BOLUS USING THE BLOOD GLUCOSE METER, IT SIGNALS IMMEDIATELY THAT THE BOLUS WAS DELIVERED. THE INFUSION DEVICE DOES NOT "TICK", AND WHEN SHE CHECKS THE HISTORY, NO BOLUS HAS BEEN DELIVERED. MOTHER THEN USES THE BUTTONS ON THE INFUSION DEVICE TO PROGRAM THE BOLUS. NO WARNING SIGNALS WERE DISPLAYED ON THE INFUSION DEVICE TO INDICATE THE BOLUS WAS NOT DELIVERED. PATIENT'S BLOOD GLUCOSE HAS BEEN ELEVATED ABOVE 10 MMOL/L (180 MG/DL) LATELY. ON (B)(6) 2011, PATIENT WAS AT SOCCER SCHOOL AND STARTED TO VOMIT. AN ADULT MEASURED PATIENT'S BLOOD GLUCOSE, AND IT WAS 25 MMOL/L (450 MG/DL). HE DELIVERED A BOLUS TO THE PATIENT, AND BLOOD GLUCOSE DECREASED TO 17 MMOL/L (306 MG/DL). PATIENT WAS THEN TAKEN TO A HEALTH CARE CENTER. PATIENT'S KETONE MEASUREMENT WAS 4, AND HE WAS TRANSFERRED TO A PEDIATRIC HOSPITAL AND RELEASED AT 12:00 P.M. THE NEXT DAY. MOTHER REPORTED THE HOSPITAL DISCONNECTED THE INFUSION DEVICE, AND HOSPITAL PERSONNEL WERE UNSURE WHY BLOOD GLUCOSE WAS SO HIGH. PATIENT'S TEACHERS USE THE BOLUS CALCULATOR TO DELIVER BOLUSES WHILE PATIENT IS AT SCHOOL, AND HIS MOTHER DOES THIS AT HOME. NO INSULIN LEAKAGE OR INFUSION SET PROBLEMS WERE REPORTED. INFUSION DEVICE AND BLOOD GLUCOSE METER WERE REPLACED AND REQUESTED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization| R INSULIN INFUSION SET:| (DATE OF TX: (B)(6))| INSULIN (DATE OF TX: (B)(6))