BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2182550 · Received July 19, 2011

    Report

    Report Number
    2183996-2011-02077
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    April 1, 2011
    Report Date
    July 4, 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
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PT REPORTED "THINGS WERE NOT GOING SO WELL" OVER THE PAST FEW MONTHS, AND THEY WANTED TO STOP USING THE INFUSION DEVICE. PT WAS THEN ADMITTED TO THE HOSPITAL FOR HYPERGLYCEMIA. PT SWITCHED TO THE BACKUP INFUSION DEVICE AT REQUEST OF INTERNIST FOLLOWING ADMISSION TO THE HOSPITAL, AND SINCE THE MOMENT, THERE HAVE BEEN NO FURTHER CONCERNS. PT IS DOING "GOOD" AND HAS NORMAL BLOOD GLUCOSE VALUES. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO ADDITIONAL INFO 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 Hospitalization| R INSULIN| INSULIN INFUSION SET