BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1882855 · Received October 22, 2010

    Report

    Report Number
    2531779-2010-01810
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. THE EVALUATION REVEALED THAT THE CONTRAST AND DOWN BUTTONS WERE INTERMITTENTLY RESPONDING. THE DOWN ARROW BUTTON CONTACT WAS ALSO MISALIGNED. IN ADDITION, THE AUDIO BOLUS, UP AND OK BUTTONS WERE RESPONSIVE AND SCROLLING WAS NOT OBSERVED DURING INVESTIGATION.

    Description of Event or Problem · 1

    THE PT REPORTED KEYPAD RESPONSES ARE MORE SENSITIVE AND RESPOND TO THE SLIGHTEST TOUCH. THE PT ALSO REPORTED THAT WHEN USING THE AUDIO BOLUS BUTTON DELIVERY IS INTERMITTENTLY CANCELLING DUE TO BUTTON PRESSES. THE 'UP' AND 'DOWN' BUTTONS RESPOND TO THE SLIGHTEST PRESS AND SCROLLS THROUGH SCREENS TOO QUICKLY AND BUTTONS ARE STICKING. THE RPTR DENIES THAT THE PUMP IS EXPOSED TO MOISTURE OR CLEANING SOLVENTS.

    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 57 YR