BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1930477 · Received November 30, 2010

    Report

    Report Number
    2531779-2010-02634
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Report Date
    November 2, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 APPEARED TO BE INTACT WITH NO LIFTING OR PEELING OBSERVED, THE "UP/DOWN/CONTRAST" KEYPAD BUTTONS INTERMITTENTLY RESPONDED TO USER INPUT, THE OK KEYPAD BUTTON REQUIRED EXCESSIVE FORCE TO ACTIVATE DURING TESTING, IT WAS OBSERVED THAT THE CONTRAST KEY CONTACT WAS MISALIGNED, THE "UP/DOWN/OK/CONTRAST" KEY CONTACTS BECAME INVERTED WHEN PRESSED AND DID NOT ALWAYS SPRING BACK AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION UNDER ALL THE KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. REPORTEDLY, THE KEYPAD IS UNRESPONSIVE AND THE OK KEYPAD BUTTON STICKS WHEN PRESSED, OTHER KEYPAD BUTTONS SPRING BACK AS NORMAL AND KEYPAD 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 NONE LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1