BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2011695 · Received March 4, 2011

    Report

    Report Number
    2183996-2011-00402
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    February 16, 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
    GM
    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

    THE PT'S DIABETES COUNSELOR REPORTED THE PT EXPERIENCED ELEVATED BLOOD GLUCOSE OF OVER 500 MG/DL. THE PT BOLUSED THROUGH THE INFUSION DEVICE BUT WAS UNABLE TO LOWER BLOOD GLUCOSE. THE PT WAS HOSPITALIZED ON (B)(6) 2011 AS A RESULT. THE PT'S NORMAL BLOOD GLUCOSE LEVEL IS 110-120 MG/DL. THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE IS WET. NO FURTHER INFO IS AVAILABLE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR EVAL.

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