BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1872144 · Received October 11, 2010

    Report

    Report Number
    2531779-2010-01553
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 12, 2010
    Report Date
    September 12, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: ALL BUTTONS CLICK AND SPRING BACK NORMALLY, THERE WAS NO DAMAGE OBSERVED TO THE KEYPAD, THE PUMP INTERMITTENTLY RESPONDED TO UP ARROW BUTTON PRESSES, AND THERE WAS ADHESIVE/CONTAMINATION FOUND UNDER THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    THE PT'S MOTHER CLAIMED THAT THE UP ARROW BUTTON STARTED INTERMITTENTLY STICKING 1-2 WEEKS AGO, REQUIRES MULTIPLE PRESSES FOR THE PUMP TO RESPOND. THE REPORTER INDICATED THAT THE BUTTON FEELS FLAT WHEREAS THE OTHER BUTTONS FEEL NORMAL. THE REPORTER DENIES WATER EXPOSURE OR CLEANING PRODUCTS. THE PUMP REPORTEDLY STILL DELIVERS INSULIN AS EXPECTED.

    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 17 YR