BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2071911 · Received April 28, 2011

    Report

    Report Number
    2531779-2011-02960
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP WAS RETURNED TO ANIMAS. EVALUATION REVEALED CONTAMINATION UNDER KEYPAD BUTTON CONTACTS AND THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY ACTIVATING PUMP FUNCTIONS WHEN PRESSED. THE PUMP DISPLAY SCREEN WAS DIM HOWEVER THE ISSUE IS NOT RELATED TO KEYPAD BUTTON FUNCTION.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT WHITE TEXT AND YELLOW HIGHLIGHTS "GHOST" OR "BURN" BETWEEN MENU SCREENS. THIS IS NOT LIKELY TO CAUSE AN ADVERSE EVENT BECAUSE IT IS GENERALLY OBVIOUS AND DETECTABLE BY THE USER AND DOES NOT AFFECT INSULIN DELIVERY FUNCTIONS. THE BUTTONS WERE REPORTEDLY ALSO INTERMITTENTLY STICKING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1