BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2141874 · Received June 28, 2011

    Report

    Report Number
    2531779-2011-04512
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Report Date
    May 31, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS AND EVALUATED. A LEAK TEST WAS PERFORMED AND THE DISPLAY LENS WAS FOUND TO HAVE LEAK. THE KEYPAD COVER WAS LOOSE ALONG THE SIDE OF KEYPAD BESIDE THE UP AND DOWN ARROW BUTTONS. TESTING CONFIRMED INTERMITTENT RESPONSES TO BUTTON PRESSES ON THE KEYPAD FOR ALL BUTTONS. MULTIPLE BUTTON PRESSES WERE REQUIRED BEFORE THE BUTTONS WOULD ENGAGE. THE BUTTONS DID NOT HAVE NORMAL SPRING BACK AND CLICK. THE KEYPAD WAS REMOVED AND ADHESIVE WAS FOUND UNDER THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS ON BEHALF OF HER DAUGHTER (THE PATIENT) ALLEGING THAT KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE PATIENT CLAIMED THAT THE PUMP WAS NOT RESPONDING TO BUTTON PRESSES. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE.

    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 16 YR