BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1884689 · Received October 25, 2010

    Report

    Report Number
    2531779-2010-01853
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. THE EVAL REVEALED THAT THE KEYPAD WAS INTACT WITH NO VISIBLE DAMAGE. THE DOWN ARROW BUTTON WAS UNRESPONSIVE AND SLOW TO RESPOND TO BUTTON PRESSES. THE EVAL ALSO REVEALED THAT THERE WAS CONTAMINATION UNDERNEATH THE BUTTONS.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE DOWN ARROW BUTTON IS NOT RESPONDING ON KEYPAD. THE PT ALSO MENTIONS THAT THE DOWN ARROW BUTTON STOPPED RESPONDING AFTER MULTIPLE PRESSES AND DOES NOT CLICK AND SPRING BACK AS IT SHOULD. THE KEYPAD IS INTACT AND ALL OTHER BUTTONS ARE WORKING.

    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 9 YR