BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1882709 · Received October 21, 2010

    Report

    Report Number
    2531779-2010-01795
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 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 HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED THAT THE PUMP WAS INTERMITTENTLY UNRESPONSIVE TO OK, UP ARROW, DOWN ARROW, AND BOLUS BUTTON PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE/CONTAMINATION WAS OBSERVED UNDER THE BUTTON CONTACTS. THE BOLUS BUTTON WAS FOUND TO BE TORN.

    Description of Event or Problem · 1

    THE PT CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS INTERMITTENTLY UNRESPONSIVE TO KEYPAD BUTTON PRESSES. THE PT ALSO CLAIMED THAT THE BUTTONS WERE INTERMITTENTLY NOT CLICKING OR SPRINGING BACK. THE PT DENIED THAT THE PUMP WAS EXPOSED TO MOISTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR