BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1963911 · Received January 11, 2011

    Report

    Report Number
    2531779-2011-00078
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Report Date
    December 8, 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

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARED INTACT WITH NO LIFTING OR PEELING OBSERVED, THE UP/DOWN/OK KEYPAD BUTTONS INTERMITTENTLY RESPONDED TO USER INPUTS DURING TESTING. THE CONTRAST KEYPAD BUTTON REQUIRED EXCESSIVE FORCE TO ACTIVATE DURING TESTING. IT WAS OBSERVED THAT THE CONTRAST KEY CONTACT WAS INVERTED. THE UP/DOWN/OK KEY CONTACTS BECAME INVERTED WHEN PRESSED AND DID NOT ALWAYS SPRING BACK, AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE UP ARROW KEYPAD BUTTON REPORTEDLY NEEDS TO BE PRESSED SEVERAL TIMES FOR A RESPONSE. THE PT CLAIMED THAT THE BUTTON APPEARS MORE DEPRESSED THAN THE OTHER KEYPAD BUTTONS. KEYPAD IS INTACT. 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 CORP. ANIMAS 2020

    Patients

    Seq Age Sex Outcome Treatment
    1