BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1894848 · Received November 5, 2010

    Report

    Report Number
    2531779-2010-02142
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Report Date
    October 6, 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 FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARED SWOLLEN, THE UP KEY CONTACT WAS MISALIGNED, ALL KEY CONTACTS ARE INVERTED AND DO NOT ALWAYS SPRING BACK, AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION UNDER THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    THE PT CLAIMED THAT THE PUMP INTERMITTENTLY RESPONSIVE TO THE OK AND ARROW BUTTONS. THIS REPORTED ISSUE CAN IMPACT INSULIN DELIVERY. THE PUMP REPORTEDLY IS "RARELY" EXPOSED TO WATER (2X/YEAR) AND THERE ARE NO SIGN OF DAMAGE TO THE KEYPAD. 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 SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1