BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2211579 · Received August 15, 2011

    Report

    Report Number
    2531779-2011-05878
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Report Date
    March 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARED INTACT WITH NO LIFTING OR PEELING OBSERVED; HOWEVER, TESTING CONFIRMED INTERMITTENT RESPONSES TO BUTTON PRESSES ON ALL KEYPAD BUTTONS. IN ADDITION, THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION FOUND UNDER ALL KEY CONTACTS WHEN THE KEYPAD WAS REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE PATIENT CLAIMED THE UP AND DOWN KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE WHEN PRESSED. IN ADDITION, THE PATIENT REPORTED THAT THE BUTTONS ALSO APPEARED TO STICK CAUSING THE CURSOR TO SCROLL. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 27