BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4113855 · Received September 24, 2014

    Report

    Report Number
    2531779-2014-27299
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Report Date
    September 12, 2014
    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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/12/2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE KEYPAD IS CUT AND TORN UNDER THE DOWN KEY. A DAMAGED KEYPAD WILL ALLOW CONTAMINATION TO PERMEATE THE BUTTON CONTACTS NEGATIVELY IMPACTING THE BUTTON FUNCTION. THE DAMAGED KEYPAD IS OBVIOUS AND DETECTABLE AND SHOULD ALERT THE USER TO DISCONTINUE USE OF THE PUMP. EVALUATION REVEALED THAT ALL OF THE KEYS RESPOND APPROPRIATELY AND THERE WAS NO CONTAMINATION UNDER THE BUTTONS. THE DISPLAY WAS FOUND TO BE DIM AND PINK.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED THAT THE DISPLAY WAS DIM AND PINK. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 09/12/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594375 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR