BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIGO INSULIN PUMP

    MDR report key: 559256 · Received May 7, 2004

    Report

    Report Number
    1066380-2004-00002
    Event Type
    Malfunction
    Date Received
    May 7, 2004
    Date of Event
    January 23, 2004
    Report Date
    May 4, 2004
    Manufacturer
    NIPRO DIABETES SYSTEMS, INC.
    Product Code
    LZG
    Removal / Correction Number
    PENDING RECEIPT FROM FDA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PER PT, ON THREE OCCASIONS DURING RETRACT DRIVE AND PRIMING, GREATER THAN 20 MINUTES FOR DRIVE TO ENGAGE.

    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 47 YR