BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3812251 · Received May 15, 2014

    Report

    Report Number
    2531779-2014-13705
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/30/2014 WITH THE FOLLOWING FINDINGS: THE OK, AND UP BUTTONS RESPONDED INTERMITTENTLY TO TESTING AND THE KEYPAD COVER WAS OBSERVED TO BE PEELING AWAY FROM THE BASE. THE CONTRAST BUTTON CONTACT WAS OBSERVED TO BE MISSING AND THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED ON THE THREADS. THE DISPLAY WAS OBSERVED TO BE DIM, FADING AND REDDISH IN COLOR. THE BOLUS BUTTON COVER WAS OBSERVED TO BE TORN AND RESPONDED NORMALLY TO TESTING. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER THE UP AND DOWN 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. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED INTERMITTENT FUNCTIONALITY OF THE OK AND UP KEYPAD BUTTONS, A MISSING CONTRAST BUTTON CONTACT, A CRACKED BATTERY COMPARTMENT, A DIM, RED AND FADING DISPLAY SCREEN, AND CONTAMINATION UNDER THE UP AND DOWN KEYPAD BUTTON CONTACTS. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 04/30/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291940 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR