BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1921820 · Received December 7, 2010

    Report

    Report Number
    2531779-2010-02758
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION AND EVALUATED. THE KEYPAD APPEARED TO BE INTACT (NO LIFTING OR PEELING OBSERVED; HOWEVER, THE BACKLIGHT BUTTON AND UP ARROW BUTTONS WERE INTERMITTENTLY RESPONDING DURING TESTING, AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION UNDER THE ALL KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OK BUTTON WAS SLOW IN ACTIVATING THE DESIRED PUMP FUNCTIONS. THE KEYPAD IS REPORTEDLY INTACT AND THE PUMP REPORTEDLY HAS NOT BEEN EXPOSED TO MOISTURE. 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 CORPORATION ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1