BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3181271 · Received June 21, 2013

    Report

    Report Number
    2531779-2013-08701
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/22/2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE INTACT. TESTING REVEALED THAT ALL KEYPAD BUTTONS WERE RESPONSIVE TO BUTTON PRESSES. THE KEYPAD BUTTONS WERE FOUND TO HAVE NORMAL SPRING BACK AND CLICK. NO CONTAMINATION WAS FOUND UNDER THE KEY CONTACTS. UNRELATED TO THE COMPLAINT, MOISTURE DROPLETS WERE FOUND BEHIND THE DISPLAY LENS. A LEAK TEST WAS PERFORMED AND THE DISPLAY LENS WAS FOUND TO BE LEAKING. ALSO UNRELATED THE VIBRATORY FEATURE WAS FOUND NOT BE WORKING ON THE PUMP. THE PUMP COVER WAS OPENED; MOISTURE RESIDUE WAS FOUND ON THE INTERNAL COMPONENTS AND PCB; CORROSION WAS FOUND ON THE VIBRATION MOTOR.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER STATED THE OK BUTTON WAS UNRESPONSIVE AND SWIMMING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282886 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR