BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1972613 · Received January 13, 2011

    Report

    Report Number
    2531779-2011-00267
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Report Date
    December 16, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARS TO BE INTACT WITHOUT ANY OBSERVATION OF PHYSICAL DAMAGE SUCH AS LIFTING OR PEELING. THE ISSUE WITH THE KEYPAD BUTTON MALFUNCTION WAS CONFIRMED THROUGH PRODUCT ANALYSIS. THE "DOWN BUTTON" IS NON RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD ADHESIVE/CONTAMINATION FOUND UNDER "DOWN" KEY CONTACTS.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING REPORTED DUE TO AN ALLEGED KEYPAD MALFUNCTION. KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THERE WAS NO REPORT OF PRODUCT MISUSE. THE KEYPAD DID NOT APPEAR TO BE PEELED OR TORN. FURTHERMORE, THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR