BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2854864 · Received December 3, 2012

    Report

    Report Number
    2531779-2012-14183
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    November 6, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ON INVESTIGATION, THE KEYPAD WAS FOUND TO BE FULLY INTACT WITHOUT PEELING OR VISIBLE DAMAGE. ON TESTING, THE UP ARROW AND CONTRAST BUTTONS HAD INTERMITTENT RESPONSE REQUIRING MULTIPLE PRESSES TO EVOKE A RESPONSE. THE REMAINDER OF THE BUTTONS HAD NORMAL RESPONSE. THE KEYPAD COVER WAS REMOVED FOR INVESTIGATION AND REVEALED CONTAMINATION UNDER THE CONTACTS OF ALL THE KEYPAD BUTTONS.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 REPORTING THAT THE UP ARROW BUTTON WAS INTERMITTENTLY RESPONDING FOR TWO TO THREE MONTHS. THE PATIENT STATED THAT THE BUTTON WAS RESPONDING ABOUT 1 OUT OF 3 PRESSES. THE PATIENT STATED THAT THE BUTTON SYMBOLS WERE STARTING TO WEAR BUT THERE WAS NO NOTED DAMAGE TO THE KEYPAD. THE PATIENT REPORTEDLY WORE THE PUMP IN A PANTS POCKET AND DID NOT CLEAN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR