BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3895759 · Received June 25, 2014

    Report

    Report Number
    2531779-2014-18355
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    June 21, 2014
    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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP KEYPAD WAS OBSERVED TO BE INTACT. THE KEYPAD BUTTONS WERE TESTED AND ALL OF THE KEYPAD BUTTONS WERE FOUND TO BE RESPONDING APPROPRIATELY TO PRESSES. THE KEYPAD WAS REMOVED AND NO BUTTON CONTACT DEFECTS WERE OBSERVED. THE PUMP WAS OPENED AND MOISTURE WAS OBSERVED ON THE PUMP KEYPAD FLEX CABLE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE UP, DOWN, OK, AND CONTRAST BUTTONS WERE UNDER RESPONSIVE TO BUTTON PRESSES. 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
    371652 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR