BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1884688 · Received October 25, 2010

    Report

    Report Number
    2531779-2010-01858
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE KEYPAD WAS FOUND TO BE PEELING OFF THE PUMP. THE 'UP' AND 'DOWN' BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING. THE UP AND DOWN BUTTON CONTACTS WERE FOUND TO BE MISALIGNED. VISUAL INSPECTION REVEALED A BATTERY COMPARTMENT CRACK.

    Description of Event or Problem · 1

    THE PT'S FATHER REPORTED THAT THE KEYPAD IS DETACHING FROM THE PUMP NEAR THE DOWN ARROW AND THE DOWN ARROW IS NOT ALWAYS RESPONDING. THE PT REPORTS NOT EXPOSING THE PUMP TO WATER OR CLEANING PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR