BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 539399 · Received August 13, 2004

    Report

    Report Number
    2531779-2004-00043
    Event Type
    Other
    Date Received
    August 13, 2004
    Date of Event
    July 16, 2004
    Report Date
    July 16, 2004
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    USER ADMITTED TO HOSPITAL WITH DKA. PUMP TO BE REPLACED AND RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization