BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1982614 · Received January 13, 2011

    Report

    Report Number
    2531779-2011-00297
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Report Date
    December 18, 2010
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 INTACT WITH NO LIFTING OR PEELING OBSERVED. THE UP/DOWN KEYPAD BUTTONS RESPONDED INTERMITTENTLY TO USER INPUTS DURING TESTING, THE OK/CONTRAST KEYPAD BUTTONS REQUIRED EXCESSIVE FORCE TO ACTIVATE DURING TESTING. IT WAS OBSERVED THAT THE OK/CONTRAST KEY CONTACTS WERE INVERTED, THE UP/DOWN KEY CONTACTS BECAME INVERTED WHEN PRESSED AND DID NOT ALWAYS SPRING BACK AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION FOUND 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 UP/DOWN/OK KEYPAD BUTTONS ARE REPORTEDLY NOT RESPONDING WHEN PRESSED. THE PT STATED THAT THE BUTTONS STICK CAUSING CURSOR TO SCROLL. IN ADDITION, THE PT REPORTED THAT THE BUTTONS DO NOT CLICK AND SPRING BACK. THE PT DENIED ANY DAMAGE TO THE KEYPAD. 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