BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2071158 · Received April 27, 2011

    Report

    Report Number
    2531779-2011-02935
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 20, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). FOR DATE OF EVENT, THE USER STATED THE ISSUE OCCURRED AROUND ONE MONTH PRIOR TO CALLING ANIMAS ((B)(6) 2011). THE PUMP WAS RETURNED TO ANIMAS. EVALUATION REVEALED ADHESIVE UNDER KEYPAD BUTTON CONTACTS. ALL KEYPAD BUTTONS WERE INTERMITTENTLY ACTIVATING PUMP FUNCTIONS WHEN PRESSED.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED THAT THE UP, DOWN, AND OK BUTTON CONTACTS REQUIRE SEVERAL PRESSES TO ACHIEVE A PUMP RESPONSE. THE ISSUE REPORTEDLY STARTED A MONTH PRIOR TO CONTACTING ANIMAS AND GOT PROGRESSIVELY WORSE. THE KEYPAD RUBBER IS REPORTEDLY INTACT AND THE USER DENIED ANY EXPOSURE TO CLEANING PRODUCTS. THE BUTTONS REPORTEDLY FELT FLAT AND DO NOT BOUNCE OR SPRING BACK NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR