BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2120330 · Received June 2, 2011

    Report

    Report Number
    2183996-2011-01552
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 9, 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
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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 NOT BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PT REPORTED THE INFUSION DEVICE "DOESN¿T WORK." ON (B)(6) 2011, THE PT'S BLOOD GLUCOSE MEASURED 299 MG/DL AT 8 AM AND SHE CHANGED THE INFUSION SET AND BOLUSED THROUGH THE INFUSION DEVICE. AT 1 PM, HER BLOOD GLUCOSE WAS VERY HIGH AND SHE BOLUSED THROUGH THE INFUSION DEVICE, A TOTAL OF 50 UNITS OF INSULIN. SHE WAS VERY THIRSTY, TRIED, AND SICK. AT 4 PM, SHE WAS TAKEN BY HER PARTNER TO THE HOSP AND HER BLOOD GLUCOSE MEASURED 741 MG/DL. SHE DISCONNECTED FROM THE INFUSION DEVICE AND FOUND THE INFUSION SET CANNULA WAS BENT (COMPETITOR'S PRODUCT). ON (B)(6) 2011, THE PT WAS RELEASED FROM THE HOSP. SHE RECONNECTED TO THE INFUSION DEVICE AND NOW HAS ERRATIC BLOOD GLUCOSE. HER NORMAL BLOOD GLUCOSE RANGE IS 100-120 MG/DL. NO FURTHER INFO IS AVAILABLE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    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 54 YR Hospitalization| O| R INSULIN INFUSION SET:| INSULIN: (DATE OF TX (B)(6))| (DATE OF TX (B)(6))