BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1030269 · Received April 15, 2008

    Report

    Report Number
    2531779-2008-00212
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 15, 2008
    Report Date
    March 15, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED A DAMAGED CIRCUIT BOARD.

    Description of Event or Problem · 1

    THE PT'S MOTHER REPORTED THAT THE PUMP DATE AND TIME WERE RESETTING TO DEFAULT VALUES, WITHOUT INTERVENTION AND THE PUMP EXHIBITED AN AUDIBLE "RATTLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1250

    Patients

    Seq Age Sex Outcome Treatment
    1