BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1894844 · Received November 5, 2010

    Report

    Report Number
    2531779-2010-02160
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD WAS TORN OFF AT THE CONTRAST BUTTON, ALL KEYPAD BUTTONS WERE NOT RESPONDING WHEN PRESSED, THE CONTRAST KEY CONTACT WAS MISSING, THE UP ARROW KEY CONTACT WAS INVERTED, AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION UNDER THE ALL KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP IS NOT RESPONDING WHEN THE UP AND DOWN ARROW BUTTONS ARE PRESSED AND THE BUTTONS FEEL FLAT. THE PT'S FATHER ALSO INDICATED THAT THERE IS A TEAR AT THE UP ARROW BUTTON. THE PUMP REPORTEDLY HAS NOT BEEN EXPOSED TO WATER. 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 16 YR