BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1983281 · Received February 2, 2011

    Report

    Report Number
    2531779-2011-00681
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Report Date
    January 7, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL AND EVALUATED. THE KEYPAD APPEARED TO BE INTACT AND ALL BUTTONS RESPONDED TO PRESSES APPROPRIATELY; HOWEVER, THERE WAS EVIDENCE OF CONTAMINATION UNDER ALL KEYPAD KEY CONTACTS.

    Description of Event or Problem · 1

    THE PT CLAIMED THAT THE AUDIO BOLUS BUTTON AND THE DOWN ARROW BUTTON WERE INTERMITTENTLY ACTIVATING THE DESIRED PUMP FUNCTIONS. THE PT DENIED EXPOSING THE PUMP TO MOISTURE AND STATED THAT THE KEYPAD AND PUMP ARE INTACT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1