BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1911913 · Received November 24, 2010

    Report

    Report Number
    2531779-2010-02528
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS AND THE EVALUATION REVEALED THAT THE KEYPAD APPEARED TO BE INTACT WITH NO LIFTING OR PEELING. THE "DOWN" KEYPAD BUTTON WAS INTERMITTENTLY RESPONDING. THE "UP" AND "OK" BUTTONS WERE RESPONSIVE TO USER INPUTS AND DID CLICK AND SPRING BACK NORMALLY. THE KEYPAD WAS REMOVED AND THE "DOWN" KEY CONTACT WAS MISALIGNED. ADDITIONALLY, THE "DOWN" KEY CONTACT BECAME INVERTED WHEN PRESSED AND DID NOT ALWAYS SPRING BACK. THERE WAS ALSO EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE "DOWN" ARROW BUTTON WAS SLOW TO RESPOND ON THE KEYPAD. THE "DOWN" ARROW BUTTON DID NOT SPRING BACK. THE REPORTER DENIES DAMAGE TO THE KEYPAD OR EXPOSURE TO MOISTURE.

    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 44 YR