BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1923930 · Received December 13, 2010

    Report

    Report Number
    2531779-2010-02824
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Report Date
    November 14, 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 EVAL. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARED INTACT, THE UP, CONTRAST AND BOLUS KEYPAD BUTTONS WERE UNRESPONSIVE TO USER INPUT AND DID NOT SPRING BACK WHEN PRESSED, IT WAS OBSERVED THAT THE CONTRAST AND UP KEYPAD CONTACTS WERE INVERTED, IT WAS OBSERVED THAT THE ACTIVATOR OF THE BOLUS KEYPAD BUTTON WAS TURNED 90 DEGREES, AND CONTAMINATION WAS OBSERVED UNDER THE UP, CONTRAST AND BOLUS KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE AUDIO AND UP ARROW KEYPAD BUTTONS UNRESPONSIVE WHEN PRESSED. IT WAS REPORTED THAT ALL THE OTHER KEYPAD BUTTONS CLICK AND SPRING BACK NORMALLY WHEN PRESSED AND THAT THE KEYPAD IS INTACT. 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