BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1942210 · Received December 21, 2010

    Report

    Report Number
    2531779-2010-03011
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARS TO BE INTACT WITH NO LIFTING OR PEELING OBSERVED, THE DOWN/OK/UP KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE TO USER INPUT DURING TESTING, ALL KEYPAD BUTTONS SPRUNG BACK NORMALLY WHEN PRESSED, AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE OK AND DOWN ARROW KEYPAD BUTTONS REPORTEDLY HAVE TO BE PRESSED SEVERAL TIMES FOR A RESPONSE. THE PT CLAIMED THAT THE KEYPAD IS INTACT. 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

    Patients

    Seq Age Sex Outcome Treatment
    1