BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1790081 · Received August 2, 2010

    Report

    Report Number
    2531779-2010-00837
    Event Type
    Injury
    Date Received
    August 2, 2010
    Date of Event
    June 26, 2010
    Report Date
    July 8, 2010
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION DEMONSTRATED THAT THE PUMP WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERED INSULIN ACCURATELY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR ELEVATED BLOOD GLUCOSE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG IR 1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization