BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1894836 · Received November 5, 2010

    Report

    Report Number
    2531779-2010-02150
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARED TO BE SWOLLEN, THE KEYPAD BUTTONS REQUIRED EXCESSIVE FORCE TO ACTIVATE, THE PUMP WAS INTERMITTENTLY RESPONDING TO THE KEYPAD BUTTONS, ALL KEY CONTACTS WERE INVERTED AND MISALIGNED, AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION UNDER THE ALL KEY CONTACTS.

    Description of Event or Problem · 1

    ACCORDING TO THE DISTRIBUTOR, THE BUTTONS WERE STICKING AND WERE DIFFICULT TO PUSH. 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1