BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 713567 · Received May 11, 2006

    Report

    Report Number
    2531779-2006-00187
    Event Type
    Injury
    Date Received
    May 11, 2006
    Date of Event
    April 11, 2006
    Report Date
    April 11, 2006
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 04/11/2006 THE PATIENT WAS HOSPITALIZED WITH DKA. THE PATIENT WAS DISCHARGED IN 04/2006 AND SUBSEQUENTLY RECEIVED EMS TREATMENT FOR HYPOGLYCEMIA IN 04/2006. THE PATIENT WAS READMITTED FOR DKA IN 04/2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. R 1000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| O