BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3080813 · Received April 26, 2013

    Report

    Report Number
    2531779-2013-05387
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 05/26/2013 DEVICE EVALUATION: ON EXAMINATION, THE KEYPAD WAS NOTED TO BE PEELING FROM THE BOTTOM TO THE OK KEYPAD BUTTON. THE KEYPAD WAS ALSO NOTED TO BE TORN AROUND THE UP AND DOWN ARROW BUTTONS. ON TESTING, NONE OF THE KEYPAD BUTTONS WERE RESPONSIVE. THE KEYPAD COVER WAS REMOVED FOR INVESTIGATION AND REVEALED CONTAMINATION UNDER THE CONTACTS OF ALL THE KEYPAD BUTTONS. THE DISPLAY WAS NOTED TO BE FADED, DISCOLORED AND DIFFICULT TO READ. A TEST DISPLAY WAS ATTACHED TO THE PUMP AND ILLUMINATED PROPERLY WITHOUT DISCOLORATION.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE USER WAS HAVING KEYPAD BUTTON ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE REPORTER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLE SHOOTING. THERE IS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182790 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR