BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIGO INSULIN PUMP

    MDR report key: 559270 · Received May 7, 2004

    Report

    Report Number
    1066380-2004-00008
    Event Type
    Malfunction
    Date Received
    May 7, 2004
    Date of Event
    February 25, 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THAT PUMP RUNS THROUGH 15 TO 20 SELF CHECKS PER DAY WITH INTERNAL ERRORS. PUMP CANNOT DELIVER BASAL, BUT IS OKAY TO DELIVER BOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMIGO INSULIN PUMP INFUSION PUMP LZG NIPRO DIABETES SYSTEMS, INC. 990004 3322

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR