BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3193543 · Received June 27, 2013

    Report

    Report Number
    2531779-2013-09147
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE EVALUATION: ON EXAMINATION, THE KEYPAD WAS NOTED TO BE TORN AT THE UP ARROW BUTTON. ON TESTING, THE UP ARROW, DOWN ARROW AND CONTRAST BUTTONS WERE UNRESPONSIVE. THE OK BUTTON WAS RESPONSIVE. THE KEYPAD COVER WAS REMOVED FOR INVESTIGATION AND REVEALED CONTAMINATION UNDER THE CONTACTS OF ALL THE KEYPAD BUTTONS. THE DISPLAY WAS NOTED TO BE DIM, FADED AND DISCOLORED. A TEST DISPLAY WAS ATTACHED TO THE PUMP AND ILLUMINATED PROPERLY WITHOUT DISCOLORATION.

    Description of Event or Problem · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2013: THE KEYPAD WAS DAMAGED. THE UP ARROW, DOWN ARROW AND CONTRAST BUTTONS WERE UNRESPONSIVE. THERE WAS CONTAMINATION UNDER THE CONTACTS OF THE KEYPAD BUTTONS. THE DISPLAY WAS DIM, FADED AND DISCOLORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293648 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR