BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1921948 · Received December 7, 2010

    Report

    Report Number
    2531779-2010-02749
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARED TO BE INTACT WITH NO LIFTING OR PEELING OBSERVED, THE UP AND DOWN KEYPAD BUTTONS INTERMITTENTLY RESPONDED TO USER INPUTS DURING TESTING, IT WAS OBSERVED THAT THE UP AND DOWN KEY CONTACTS WERE MISALIGNED, AND ALL THE KEY CONTACTS CLICKED AND SPRUNG BACK NORMALLY WHEN PRESSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE WHEN PRESSED. 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