BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2222363 · Received August 25, 2011

    Report

    Report Number
    2531779-2011-06200
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 27, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE DOWN ARROW BUTTON WAS FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES AND BUTTON STICKING WAS DUPLICATED DURING TESTING. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS OBSERVED UNDER ALL OF 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

    IT WAS REPORTED THAT THE DOWN ARROW BUTTON WAS STICKING IN THE DOWN POSITION AND SCROLLING FOR ABOUT A WEEK. THE PATIENT REPORTEDLY WORE THE PUMP ATTACHED TO A BELT 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 59 YR