BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2072918 · Received April 2, 2011

    Report

    Report Number
    2531779-2011-02131
    Event Type
    Malfunction
    Date Received
    April 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. DURING INVESTIGATION, IT WAS FOUND THAT ALL KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. IT WAS ALSO FOUND THAT THE DOWN ARROW KEY CONTACT WAS OBSERVED TO BE MISALIGNED. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUTTONS ON THE PUMP REQUIRE SEVERAL PRESSES. IT WAS REPORTED THAT THE KEYPAD IS INTACT AND THE PUMP IS NOT EXPOSED TO WATER.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1