BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1882707 · Received October 21, 2010

    Report

    Report Number
    2531779-2010-01805
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED THAT THE PUMP WAS INTERMITTENTLY UNRESPONSIVE TO CONTRAST, UP ARROW, AND DOWN ARROW BUTTON PRESSES. THE OK BUTTON WAS ALSO FOUND TO BE STICKING AND RESPONDED TO HARD PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE/CONTAMINATION WAS OBSERVED UNDER THE BUTTON CONTACTS. THE KEYPAD WAS FOUND TO BE LIFTED NEAR THE UP ARROW BUTTON.

    Description of Event or Problem · 1

    THE RPTR CONTACTED ANIMAS ON BEHALF OF HIS SO (THE PT) ALLEGING THAT THE OK BUTTON ON THE PUMP WAS STICKING.

    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 3 YR