BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3180872 · Received June 20, 2013

    Report

    Report Number
    2531779-2013-08685
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    May 24, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DAMAGED) ISSUE. THE DISPLAY ON THE ANIMAS PUMP REPORTEDLY IS PARTIALLY DIM IN SOME AREA. THERE WAS NO TRAUMA OR MOISTURE ISSUE. THE CONTRAST WAS SET ACCORDINGLY BUT THE ISSUE IS NOT RESOLVED. THE PUMP IS BEING RETURNED FOR INVESTIGATION. THERE IS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE DISPLAY IS OBSERVED TO BE DIM AND REDDISH. PUMP WAS OPENED AND A TEST DISPLAY SCREEN WAS MOUNTED, THE PUMP WAS ABLE TO POWER UP WITH A FULLY ILLUMINATED AND COLORED DISPLAY. THERE WAS AN UNIDENTIFIED DISPLAY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281327 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR