BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2072946 · Received April 3, 2011

    Report

    Report Number
    2531779-2011-02139
    Event Type
    Malfunction
    Date Received
    April 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. DURING INVESTIGATION, IT WAS FOUND THAT ALL KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUTTONS ARE STICKING AND VERY HARD TO PRESS TO PROGRAM CORRECTLY. IT WAS ALSO REPORTED THAT THERE IS NO STRUCTURAL DAMAGE TO KEYPAD AND NO WATER EXPOSURE TO PUMP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1