BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1934092 · Received December 2, 2010

    Report

    Report Number
    2531779-2010-02687
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Report Date
    November 3, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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, DOWN AND CONTRAST KEYPAD BUTTONS INTERMITTENTLY RESPONDED TO USER INPUTS DURING TESTING, IT WAS OBSERVED THAT THE UP AND DOWN KEY CONTACTS WERE INVERTED, IT WAS OBSERVED THAT THE OK AND CONTRAST KEY CONTACTS BECAME INVERTED WHEN PRESSED, AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION UNDER ALL THE KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE ARROW KEYPAD BUTTONS INTERMITTENTLY NOT RESPONDING WHEN PRESSED. REPORTED KEYPAD BUTTONS ALSO FEEL STICKY WHEN PRESSED, BUT KEYPAD 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