BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2011714 · Received March 4, 2011

    Report

    Report Number
    2183996-2011-00391
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    January 21, 2011
    Report Date
    February 21, 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. 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

    THE PATIENT REPORTED BEING HOSPITALIZED ON (B)(6) 2011, WITH ELEVATED BLOOD GLUCOSE OF 30 MMOL/L (540 MG/DL). THE PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS 5-11 MMOL/L (90-198 MG/DL). SHE CHANGED THE INFUSION SET SEVERAL TIMES AND BOLUSED THROUGH THE INFUSION DEVICE BUT WAS UNABLE TO LOWER HER BLOOD GLUCOSE. SHE BELIEVES THE INFUSION DEVICE DELIVERS TOO LITTLE INSULIN. NO FURTHER INFORMATION IS AVAILABLE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    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 51 YR Hospitalization| O| R INSULIN INFUSION SET| INSULIN