BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2221371 · Received August 24, 2011

    Report

    Report Number
    2531779-2011-06161
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4): TESTING CONFIRMED INTERMITTENT RESPONSES TO BUTTON PRESSES ON THE 'UP' AND 'CONTRAST' BUTTONS. THE KEYPAD WAS TORN, PEELING AND LIFTING, EXPOSING THE BUTTON CONTACTS. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS NOTED UNDER THE CONTACTS OF ALL BUTTONS. UNRELATED TO THIS COMPLAINT, THE DISPLAY IS FADED AND DISCOLORED. WHEN A TEST SCREEN WAS USED THE DISPLAY WAS FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTON HAD A DELAYED RESPONSE ON OCCASION. IT WAS ALSO REPORTED THAT THE KEYPAD WAS LOOSE AT THE BUTTONS BUT WAS NOT COMING LOOSE FROM THE PUMP AND THE KEYPAD WAS NOT TORN. THE PATIENT REPORTEDLY WORE THE PUMP ATTACHED TO A BELT AND DID NOT CLEAN THE PUMP. THE PATIENT REFUSED TO RETURN THE PUMP AS THE BUTTONS WERE REPORTEDLY STILL RESPONDING.

    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 40 YR