BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1983272 · Received February 2, 2011

    Report

    Report Number
    2531779-2011-00674
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Report Date
    January 6, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL AND EVALUATED. THE KEYPAD APPEARED TO BE INTACT; HOWEVER, THE OK BUTTON WAS INTERMITTENTLY RESPONDING TO USER INPUTS AND THERE WAS EVIDENCE OF CONTAMINATION UNDER THE DOWN ARROW KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UP/DOWN ARROW, CONTRAST, AND OK BUTTONS WERE INCREASINGLY NOT ACTIVATING THE DESIRED PUMP FUNCTIONS. THE PUMP HAS NOT BEEN EXPOSED TO MOISTURE AND THE KEYPAD IS NOT PEELING; HOWEVER, THE BUTTONS FEEL FLAT. 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

    Patients

    Seq Age Sex Outcome Treatment
    1