BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1942805 · Received December 20, 2010

    Report

    Report Number
    2531779-2010-02972
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Report Date
    November 20, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARS TO BE INTACT WITH NO LIFTING OR PEELING OBSERVED, THE DOWN KEYPAD BUTTON WAS SENSITIVE TO BUTTON PRESSES AND SPRUNG BACK WHEN PRESSED, THE UP, OK AND CONTRAST KEYPAD BUTTONS WERE RESPONSIVE TO USER INPUT AND SPRUNG BACK AS NORMAL, IT WAS OBSERVED THAT THE DOWN KEYPAD CONTACT WAS MISALIGNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. ALL THE KEYPAD BUTTONS, EXCEPT FOR THE UP ARROW BUTTON, ARE REPORTEDLY VERY SENSITIVE AND ACTIVATE SCROLLING ON THE DISPLAY WITH MINIMAL TOUCH. KEYPAD IS INTACTS. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    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