BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2103510 · Received May 26, 2011

    Report

    Report Number
    2531779-2011-03720
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP WAS RETURNED TO ANIMAS. EVALUATION REVEALED THAT ALL KEYPAD BUTTONS WERE INTERMITTENTLY ACTIVATING PUMP FUNCTIONS WHEN PRESSED. ADHESIVE WAS FOUND UNDER THE KEYPAD BUTTON CONTACTS.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT THE UP AND DOWN BUTTONS DID NOT ACTIVATE DESIRED PUMP FUNCTIONS WHEN PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 1200 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1