BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1894845 · Received November 5, 2010

    Report

    Report Number
    2531779-2010-02156
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARED TO BE INTACT (NO LIFTING OR PEELING), BUT ALL THE KEYPAD BUTTONS WERE UNRESPONSIVE TO USER INPUT, THE UP ARROW KEY CONTACT WAS MISALIGNED, AND THE OK KEY CONTACT WAS INVERTED AND DID NOT SPRING BACK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP IS UNRESPONSIVE WHEN THE OK BUTTON IS PRESSED AND A SINGLE PRESS OF THE ARROW BUTTONS OFTEN CAUSES THE CURSOR TO SCROLL. THE PUMP REPORTEDLY HAS NOT BEEN EXPOSED TO WATER AND DOES NOT HAVE ANY VISIBLE DAMAGE TO THE BUTTONS. 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1