BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2050584 · Received March 15, 2011

    Report

    Report Number
    2531779-2011-01599
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 12, 2011
    Report Date
    February 12, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARS TO BE INTACT WITHOUT ANY OBSERVATION OF PHYSICAL DAMAGE SUCH AS LIFTING OR PEELING. THE ISSUE WITH THE KEYPAD BUTTON MALFUNCTION WAS CONFIRMED THROUGH PRODUCT ANALYSIS. THE "UP/DOWN/OK AND CONTRAST" KEYPAD BUTTONS ARE INTERMITTENTLY RESPONDING AND REQUIRES EXCESSIVE FORCE TO ACTIVATE DURING TESTING. THE "UP/DOWN/OK AND CONTRAST" KEY CONTACTS DO NOT ALWAYS SPRING BACK WHEN PRESSED. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER THE KEY CONTACTS.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING REPORTED DUE TO AN ALLEGED KEYPAD MALFUNCTION. KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. 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.

    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 15 YR