BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2213634 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05958
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. EVALUATION CONFIRMED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY ACTIVATING DESIRED PUMP FUNCTIONS WHEN PRESSED. THE BUTTONS DO NOT SPRING BACK OR CLICK NORMALLY. CONTAMINATION WAS FOUND UNDER THE BUTTON CONTACTS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    THE PATIENT STATED THAT THE UP, DOWN, AND OK BUTTONS REQUIRE MULTIPLE PRESSES TO ACTIVATE A PUMP RESPONSE. THE HIGHLIGHT ON THE PUMP MENU SCREENS THEN SCROLL WHEN THE BUTTON ENGAGES AND THE BUTTONS CLICK/SPRING BACK NORMALLY. THE UP ARROW BUTTONS REPORTEDLY FEELS "MUSHY" AND LOOSE. THE PATIENT DOES NOT CLEAN THE PUMP. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR