BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1900049 · Received November 8, 2010

    Report

    Report Number
    2531779-2010-02176
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. DURING EVALUATION THE PUMP RESPONDED NORMALLY TO BUTTON PRESSES. THERE WAS ADHESIVE FOUND UNDER THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    THE PT'S MOTHER REPORTED THAT THE PUMP WAS NOT APPROPRIATELY RESPONDING TO PRESSES OF THE ARROW BUTTONS. SHE SAYS IT TAKES MULTIPLE BUTTON PRESSES TO ACHIEVE A PUMP RESPONSE. SHE ALSO SAYS THAT THE FREQUENCY OF UNRESPONSIVENESS IS INCREASING. SHE DENIES THAT THE PUMP IS EXPOSED TO MOISTURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR