BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1901566 · Received November 10, 2010

    Report

    Report Number
    2531779-2010-02197
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 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

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED THAT THE KEYPAD WAS INTACT AND NO LIFTING OR PEELING WAS OBSERVED. ALL BUTTONS RESPONDED INTERMITTENTLY AND REQUIRED EXCESSIVE FORCE TO ACTIVATE. DURING INVESTIGATION, THE KEY CONTACTS WERE FOUND TO BE INVERTED AND DID NOT ALWAYS SPRING BACK. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER THE KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD STARTED PEELING AND THE BUTTONS WERE STICKING. A FAMILY MEMBER NOTED THAT THE PUMP WAS SCROLLING THROUGH SCREENS WITHOUT USER INTERVENTION. THE PT WEARS THE PUMP IN HIS POCKET WITH A CLIP, THERE IS NO MOISTURE EXPOSURE, AND NO CLEANERS ARE USED ON THE KEYPAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. K042873 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR