BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1921952 · Received December 7, 2010

    Report

    Report Number
    2531779-2010-02744
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED THAT THE PUMP WAS INTERMITTENTLY NOT RESPONDING TO UP, DOWN AND OK BUTTON PRESSES. THE KEYPAD WAS REMOVED FOR FURTHER INVESTIGATION AND EVIDENCE OF KEYPAD ADHESIVE/CONTAMINATION WAS FOUND UNDER THE KEY CONTACTS. IN ADDITION, THE UP, DOWN, AND OK KEY CONTACTS WERE OBSERVED TO BE INVERTED AND WERE NOT ALWAYS SPRINGING BACK. THE KEYPAD APPEARED TO BE INTACT WITH NO LIFTING OR PEELING.

    Description of Event or Problem · 1

    THE PT CONTACTED ANIMAS ALLEGING THAT KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE PT CLAIMED THAT THE UP AND DOWN ARROW BUTTONS REQUIRED SEVERAL PRESSES FOR THE PUMP TO RESPOND. THE PT ALSO CLAIMED THAT THE KEYPAD WAS INTACT AND THE DOWN ARROW BUTTON WAS SPRINGING BACK AS NORMAL. THE PT DENIED THAT THE DEVICE WAS EXPOSED TO WATER OR CLEANING PRODUCTS.

    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