BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2182341 · Received July 28, 2011

    Report

    Report Number
    2531779-2011-05416
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/27/2011 WITH THE FOLLOWING FINDINGS: THE BOLUS BUTTON WAS OBSERVED TO BE MISSING AND MOISTURE WAS OBSERVED UNDER THE DISPLAY LENS. THE ALL BUTTONS WERE FOUND TO BE UNRESPONSIVE TO BUTTON PRESSES. THE PUMP WAS FOUND TO BE LEAKING FROM THE BOLUS BUTTON. THE PUMP WAS OPENED AND MOISTURE WAS FOUND ON THE PCB AND SCREEN. (B)(6).

    Additional Manufacturer Narrative · 1

    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

    A FAMILY MEMBER REPORTED THAT AFTER THE PATIENT WENT SWIMMING THE PUMP SCREEN WENT BLANK AND THE KEYPAD STOPPED RESPONDING. THE PATIENT REPORTEDLY WORE THE PUMP ON THE OUTSIDE OF CLOTHING AND DID NOT CLEAN THE PUMP.

    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 16 YR