BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2041627 · Received March 10, 2011

    Report

    Report Number
    2531779-2011-01476
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE STICKING AND INTERMITTENTLY UNRESPONSIVE. A FAMILY MEMBER REPORTED THAT THE DISPLAY SCREEN APPEARS TO BE INTERMITTENTLY FROZEN DUE TO THE BUTTONS BEING UNRESPONSIVE. SHE NOTED THAT THE KEYPAD BUTTONS STICK WHEN PRESSED. THE FAMILY MEMBER STATED THAT THERE IS NO PHYSICAL DAMAGE TO THE RUBBER KEYPAD, THE PUMP IS NOT EXPOSED TO MOISTURE, AND THE PT WEARS THE PUMP IN A POUCH.

    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 11 YR