BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1942413 · Received December 23, 2010

    Report

    Report Number
    2531779-2010-03070
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    November 27, 2010
    Report Date
    November 27, 2010
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THERE 'CONTRAST' BUTTON WAS NOTED TO BE TORN ON KEYPAD. ALL BUTTONS UNRESPONSIVE AND SPRINGS BACK WHEN PRESSED. HOWEVER, THERE WAS NO REPORT OF PEELING OR TEARING ON THE OK/DOWN/UP BUTTONS.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING REPORTED DUE TO AN ALLEGED KEYPAD MALFUNCTION. THERE WAS NO REPORT OF PRODUCT MISUSE. THE KEYPAD DID NOT APPEAR TO BE PEELED OR TORN. FURTHERMORE, THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    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 3 YR