BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1934121 · Received December 2, 2010

    Report

    Report Number
    2531779-2010-02677
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED THAT THE PUMP WAS INTERMITTENTLY NOT RESPONDING TO UP, DOWN, AND OK BUTTON PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE/CONTAMINATION WAS OBSERVED UNDER THE BUTTON CONTACTS. THE UP, DOWN, AND OK BUTTON CONTACTS ALSO WERE OBSERVED TO BE INVERTED AND WERE NOT ALWAYS SPRINGING BACK. THE KEYPAD APPEARED TO BE INTACT WITH NO LIFTING OR PEELING. THERE WAS NO EVIDENCE OF MOISTURE/CORROSION FOUND ON INTERNAL COMPONENTS INSIDE THE PUMP.

    Description of Event or Problem · 1

    THE PT CONTACTED ANIMAS ALLEGING THAT KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE PT CLAIMED THAT THE AUDIO BOLUS BUTTON REQUIRED MULTIPLE PRESSES FOR THE PUMP TO RESPOND. THE PT DENIED THAT THE DEVICE WAS EXPOSED TO WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1