BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIGO INSULIN PUMP

    MDR report key: 559523 · Received May 7, 2004

    Report

    Report Number
    1066380-2004-00010
    Event Type
    Malfunction
    Date Received
    May 7, 2004
    Date of Event
    April 26, 2004
    Report Date
    May 4, 2004
    Manufacturer
    NIPRO DIABETES SYSTEMS, INC.
    Product Code
    LZG
    Removal / Correction Number
    PENDING RECIEPT FROM FDA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PER PT'S FAMILY MEMEBER, PUMP HAS INTERNAL ERROR. PUMP STOPPED WORKING IN MIDDLE OF NIGHT. PT'S FAMILY MEMEBER STATED PUMP NOT DELIVERING ENOUGH INSULIN OR NO INSULIN AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMIGO INSULIN PUMP INFUSION PUMP LZG NIPRO DIABETES SYSTEMS, INC. 990001 3211

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR