BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2043303 · Received March 15, 2011

    Report

    Report Number
    2531779-2011-01575
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. THE UP ARROW, OK AND CONTRAST KEYPAD BUTTONS DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE DOWN ARROW BUTTON REQUIRED EXCESSIVE FORCE TO ACTIVATE A RESPONSE. DURING INVESTIGATION, THE UP AND DOWN ARROW BUTTONS WERE OBSERVED TO BE MISALIGNED. IT WAS ALSO OBSERVED THAT ALL BUTTONS INTERMITTENTLY SPRING BACK WHEN PRESSED. THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER ALL THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD IS LESS RESPONSIVE. IT WAS REPORTED THAT THE PUMP WAS EXPOSED TO WATER ONE MONTH AGO (DROPPED IN TOILET).

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1