BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSETM

    MDR report key: 1893877 · Received November 1, 2010

    Report

    Report Number
    2531779-2010-02067
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    October 3, 2010
    Report Date
    October 3, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    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 SWOLLEN, THE PUMP WAS INTERMITTENTLY RESPONSIVE TO ALL KEYPAD BUTTONS AND REQUIRED EXCESSIVE FORCE TO ACTIVATE, THE UP AND DOWN ARROW KEY CONTACTS WERE MISALIGNED, THE CONTRAST KEY CONTACT WAS INVERTED, AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION UNDER THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP IS INTERMITTENTLY RESPONDING TO THE DOWN ARROW BUTTON. THE PUMP REPORTEDLY HAS NOT BEEN EXPOSED TO WATER AND THE KEYPAD IS INTACT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSETM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR