BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMIGO INSULIN PUMP

    MDR report key: 525930 · Received May 13, 2004

    Report

    Report Number
    1066380-2004-00011
    Event Type
    Other
    Date Received
    May 13, 2004
    Date of Event
    May 12, 2004
    Report Date
    May 13, 2004
    Manufacturer
    NIPRO DIABETES SYSTEMS, INC.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT IN HOSPITAL. DUE TO VOLUNTARY RECALL OF PRODUCT, PT WENT OFF OF INSULIN INFUSION PUMP. PT UNABLE TO CONTROL BLOOD GLUCOSE LEVELS AND WAS HOSPITALIZED WITH HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMIGO INSULIN PUMP INFUSION PUMP LZG NIPRO DIABETES SYSTEMS, INC. 990005 3319

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization