BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2160064 · Received July 13, 2011

    Report

    Report Number
    2531779-2011-04891
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED BACK TO ANIMAS WITH THE FOLLOWING FINDINGS. THE TESTING CONFIRMED INTERMITTENT RESPONSES TO BUTTON PRESSES ON THE UP ARROW BUTTON AND THE CONTRAST BUTTON. PRODUCT ANALYSIS REMOVED THE KEYPAD COVER TO CHECK CONDITION OF THE BUTTON CONTACTS AND NOTICED THAT THERE WAS CONTAMINATION UNDER THE CONTACTS OF ALL BUTTONS. PRODUCT ANALYSIS ALSO NOTED THAT THE BUTTON CONTACT ON THE UP ARROW BUTTON WAS INVERTED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 08/08/2011. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS. 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 CLAIMED THAT THE UP BUTTONS REQUIRED SEVERAL PRESSES TO ACTIVATE THE DESIRED PUMP FUNCTIONS. THE BACK LIGHT WAS ALSO HARD TO RESPOND. THE KEYPAD IS REPORTEDLY INTACT. THERE WAS NO ADVERSE EVENT ASSOCIATE WITH THIS COMPLAINT. THE PUMP WAS REPLACED.

    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 53 YR