BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1893633 · Received November 2, 2010

    Report

    Report Number
    2531779-2010-02033
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. DURING EVALUATION, THE CONTRAST BUTTON RESPONDED TO HARD PRESSES AND THE OK AND DOWN BUTTONS WERE INTERMITTENTLY RESPONSIVE. INVESTIGATION FOUND ADHESIVE UNDER THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE OK AND DOWN ARROW BUTTONS ON THE KEYPAD ARE INTERMITTENTLY UNRESPONSIVE. SHE STATED THAT SHE FIRST NOTICED THE ISSUE TWO MONTHS AGO, IT IMPROVED FOR A SHORT TIME, AND THEN THE PROBLEM RETURNED FOUR DAYS AGO. SHE DENIED TRAUMA TO THE KEYPAD OR WATER EXPOSURE. SHE NOTED THAT SHE WEARS THE PUMP IN A POCKET, DOES NOT USE CLEANING PRODUCTS ON THE PUMP, AND DENIES PEELING/TEARING OF THE KEYPAD. THE PATIENT STATED THAT THE KEYPAD BUTTONS CLICK AND SPRING BACK NORMALLY EXCEPT FOR THE OK BUTTON. SHE REPORTED THAT THE PUMP IS USABLE WITH MONITORING OF BUTTON PRESSES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR