BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1881303 · Received October 18, 2010

    Report

    Report Number
    2531779-2010-01726
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 18, 2010
    Report Date
    September 18, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED THAT THE PUMP WAS INTERMITTENTLY RESPONDING TO KEYPAD BUTTON PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE/CONTAMINATION WAS OBSERVED UNDER THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON BEHALF OF THE PT (HER DAUGHTER) ALLEGING THAT THE PUMP WAS INTERMITTENTLY NOT RESPONDING TO DOWN ARROW BUTTON PRESSES. THE REPORTER ALSO CLAIMED THAT THE DOWN BUTTON WAS STICKING. THE REPORTER DENIED THAT THE KEYPAD WAS PEELING OR TORN.

    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 13 YR